Product Code: GKZ FDA class 2 21 CFR 864.5220

Counter, Differential Cell

Hematology

The Differential Cell Counter is a laboratory instrument used in hematology to identify and quantify the different types of white blood cells present in a blood sample, supporting the diagnosis of infections, blood disorders, and other conditions. It is classified as FDA Class 2 (moderate risk), meaning it is subject to general controls and requires a 510(k) premarket notification before it can be marketed. The product code is GKZ and it falls under regulation 21 CFR 864.5220 within the Hematology medical specialty.

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510(k)s

380

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GKZ
Device Class: FDA class 2
Regulation Number: 864.5220
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 380 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253212	XR-Series (XR-10, XR-20) Automated Hematology Analyzers	May 27, 2026	Substantially Equivalent	Sysmex America, Inc.
K243348	Athelas Home	Feb 06, 2026	Substantially Equivalent	Athelas, Inc.
K251249	Tru Hematology Test	Jan 16, 2026	Substantially Equivalent	Truvian Sciences, Inc.
K251371	Sysmex XR-Series (XR-20) Automated Hematology Analyzer	Jun 25, 2025	Substantially Equivalent	Sysmex America, Inc.
K250943	Sysmex XR-Series (XR-10) Automated Hematology Analyzer	Jun 25, 2025	Substantially Equivalent	Sysmex America, Inc.
K243283	Alinity h-series System	Feb 20, 2025	Substantially Equivalent	Abbott Laboratories
K240402	Cito CBC System	Feb 03, 2025	Substantially Equivalent	Cytochip, Inc.
K240252	UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System	Jul 05, 2024	Substantially Equivalent	Beckman Coulter, Inc.
K232946	Yumizen H2500	May 21, 2024	Substantially Equivalent	HORIBA ABX SAS
K240636	HemoScreen Hematology Analyzer	May 02, 2024	Substantially Equivalent	Pixcell Medical Technologies
K230887	Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer	Dec 21, 2023	Substantially Equivalent	Sysmex America, Inc.
K230878	QScout Lab; QScout RLD	Nov 14, 2023	Substantially Equivalent	Ad Astra Diagnostics, Inc.
K222148	HemoScreen Hematology Analyzer	Aug 16, 2023	Substantially Equivalent	Pixcell Medical Technologies, Ltd.
K220031	Alinity h-series System	Aug 04, 2023	Substantially Equivalent	Abbott Laboratories
K210346	Sysmex XW-100 Automated Hematology Analyzer	Nov 08, 2022	Substantially Equivalent	Sysmex America, Inc.
K211840	Sight OLO	May 09, 2022	Substantially Equivalent	S.D. Sight Diagnostics , Ltd.
K200828	Athelas Home	Mar 22, 2022	Substantially Equivalent	Athelas, Inc.
K193124	Unicel DxH 800 Coulter Cellular Analysis System	Apr 16, 2020	Substantially Equivalent	Beckman Coulter
K190898	Sight OLO	Nov 01, 2019	Substantially Equivalent	Sight Diagnostics , Ltd.
K182886	Cytomics FC 500 Series (MPL or MCL) Flow Cytometer	Sep 06, 2019	Substantially Equivalent	Beckman Coulter
K190294	CELL-DYN Emerald 22 AL System	Mar 15, 2019	Substantially Equivalent	Abbott Laboratories
K181475	DxH 520 Hematology Instrument	Mar 01, 2019	Unknown	Beckman Coulter
K182389	Sysmex XN-L Automated Hematology Analyzer	Jan 25, 2019	Substantially Equivalent	Sysmex America, Inc.
K181288	Athelas One	Nov 05, 2018	Substantially Equivalent	Athelas, Inc.
K180020	HemoScreen Hematology Analyzer	Oct 29, 2018	Substantially Equivalent	Pixcell Medical Technologies, Ltd.
K171655	cobas m 511 integrated hematology analyzer	Mar 02, 2018	Substantially Equivalent	Roche Diagnostics Hematology, Inc.
K172604	XW-100 Automated Hematology Analyzer for CLIA Waived Use	Nov 06, 2017	Substantially Equivalent	Sysmex America, Inc.
K170353	ABX MICROS ES 60 OT and ABX MICROS ES 60 CT	Nov 01, 2017	Substantially Equivalent	HORIBA ABX SAS
K162977	ADVIA 2120i, ADVIA 2120	Aug 11, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics
K153538	Dextramer CMV Kit	Mar 02, 2017	Substantially Equivalent	Immudex Aps
K160538	Sysmex XN-L Automated Hematology Analyzer	Dec 22, 2016	Substantially Equivalent	Sysmex America, Inc.
K162414	UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System	Nov 29, 2016	Substantially Equivalent	Beckman Coulter, Inc.
K160429	BC-5390 Auto Hematology Analyzer	Sep 01, 2016	Substantially Equivalent	Mindray Bio-Medical Electronics Co., Ltd.
K151133	PENTRA XLR	Dec 09, 2015	Substantially Equivalent	HORIBA ABX SAS
K143577	XW-100 Automated Hematology Analyzer, XW QC CHECK	Oct 12, 2015	Substantially Equivalent	Sysmex America, Inc.
K143348	BC-3600 Auto Hematology Analyzer	Aug 21, 2015	Substantially Equivalent	Mindray Bio-Medical Electronics Co., Ltd.
K141161	ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)	Dec 20, 2014	Substantially Equivalent	HORIBA ABX SAS
K141681	SYSMEX XN SERIES	Dec 05, 2014	Substantially Equivalent	Sysmex America, Inc.
K140911	UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM	Sep 05, 2014	Substantially Equivalent	Beckman Coulter, Inc.
K120771	UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM	Mar 22, 2013	Substantially Equivalent	Beckman Coulter, Inc.
K112605	SYSMEX XN-SERIES	Oct 19, 2012	Substantially Equivalent	Sysmex America, Inc.
K111534	ABACUS 3CP	Aug 02, 2012	Substantially Equivalent	Diatron U.S., Inc.
K112755	ABACUS 5	Mar 27, 2012	Substantially Equivalent	Diatron U.S., Inc.
K110381	CELL-DYN EMERALD 22 SYSTEM	Dec 22, 2011	Substantially Equivalent	Abbott Laboratories
K102644	ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I	Nov 23, 2011	Substantially Equivalent	Siemens Healthcare Diagnostics
K102064	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	Mar 07, 2011	Substantially Equivalent	Becton, Dickinson & CO
K100489	DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771	Oct 26, 2010	Substantially Equivalent	Beckman Coulter Cellular
K090346	ADVIA 2120/2120I BODY FLUIDS	Jul 28, 2010	Substantially Equivalent	Siemens Healthcare Diagnostics
K093394	BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C	Apr 08, 2010	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K091313	SYSMEX MODEL XT-4000I	Mar 30, 2010	Substantially Equivalent	Sysmex America, Inc.
K090810	THERMO SCIENTIFIC CYTO-CAL COUNT TUBES	Sep 18, 2009	Substantially Equivalent	Microgenics Corp.
K090967	BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611	Jul 31, 2009	Substantially Equivalent	Bd Biosciences
K090013	CHEMPAQ XBC ANALYZER	Apr 21, 2009	Substantially Equivalent	Chempaq A/S
K082091	TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00	Apr 15, 2009	Substantially Equivalent	Reametrix, Inc.
K081495	CELL-DYN EMERALD SYSTEM	Feb 04, 2009	Substantially Equivalent	Abbott Laboratories
K083420	MEDONIC M SERIES	Feb 03, 2009	Substantially Equivalent	Boule Medical AB
K081930	UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM	Dec 19, 2008	Substantially Equivalent	Beckman Coulter, Inc.
K081890	SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER	Oct 10, 2008	Substantially Equivalent	Sysmex America, Inc.
K081610	SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER	Aug 29, 2008	Substantially Equivalent	Sysmex America, Inc.
K081526	FLOWCARE TLG REAGENT	Aug 14, 2008	Substantially Equivalent	Beckman Coulter, Inc.
K081213	BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010	Aug 14, 2008	Substantially Equivalent	Bd Biosciences
K072869	POINTCARE NOW SYSTEM	Jan 14, 2008	Substantially Equivalent	Pointcare Technologies, Inc.
K071562	D3 HEMATOLOGY ANALYZER, MODEL D3	Dec 11, 2007	Substantially Equivalent	Drew Scientific, Inc.
K071967	SYSMEX XE-5000	Nov 20, 2007	Substantially Equivalent	Sysmex America, Inc.
K071681	CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554	Oct 04, 2007	Substantially Equivalent	Beckman Coulter, Inc.
K063407	BC-3200 AUTO HEMATOLOGY ANALYZER	Jun 11, 2007	Substantially Equivalent	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
K071143	BD TRITEST CD3/CD4/CD45, MODEL 340383	Jun 06, 2007	Substantially Equivalent	Bd Biosciences
K071141	BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402	Jun 06, 2007	Substantially Equivalent	Bd Biosciences
K061616	COULTER LH 780 HEMATOLOGY ANALYZER	Oct 04, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K062087	BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962	Sep 14, 2006	Substantially Equivalent	Bd Biosciences
K060423	CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES	Aug 15, 2006	Substantially Equivalent	Dakocytomation California, Inc.
K061574	COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632	Jul 21, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K061667	CELL-DYN RUBY SYSTEM	Jul 10, 2006	Substantially Equivalent	Abbott Laboratories
K061150	SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES	Jul 06, 2006	Substantially Equivalent	Sysmex America, Inc.
K060375	BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166	Jun 06, 2006	Substantially Equivalent	Bd Biosciences
K060656	SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES	May 10, 2006	Substantially Equivalent	Sysmex America, Inc.
K053497	GUAVA EZCD4 SYSTEM	Apr 14, 2006	Substantially Equivalent	Guava Technologies, Inc.
K053308	ABX MICROS CRP 200, OPTION IM	Dec 29, 2005	Substantially Equivalent	Horiba Abx
K050758	CHEMPAQ XBC ANALYZER	Dec 22, 2005	Substantially Equivalent	Chempaq A/S
K052905	MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER	Nov 18, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K051459	SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER	Sep 23, 2005	Substantially Equivalent	Sysmex America, Inc.
K050421	MS 4/5 HEMATOLOGY ANALYZER	Aug 31, 2005	Substantially Equivalent	Melet Schloesing Laboratories USA
K051199	IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER	Aug 08, 2005	Substantially Equivalent	Sysmex America, Inc.
K051122	ITAG MHC TETRAMER CMV ASSAY	Aug 01, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K050436	MS 9/5 HEMATOLOGY ANALYZER	Jul 27, 2005	Substantially Equivalent	Melet Schloesing Laboratories USA
K051215	CELL-DYN SAPPHIRE SYSTEM	Jul 21, 2005	Substantially Equivalent	Abbott Laboratories
K050589	RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER	May 04, 2005	Substantially Equivalent	Sysmex America, Inc.
K050719	ABX PENTRA DX 120: OPTION SPS EVOLUTION	Apr 26, 2005	Substantially Equivalent	Horiba Abx
K050057	COULTER LH 750 HEMATOLOGY ANALYZER	Feb 10, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K043215	FLOWCARE PLG CD4 REAGENT	Jan 19, 2005	Substantially Equivalent	Beckman Coulter, Inc.
K041882	FLOWCARE SYSTEM	Nov 23, 2004	Substantially Equivalent	Pointcare Technologies, Inc.
K042724	MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER	Oct 29, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K042173	COULTER A T 5DIFF CAP PIERCE (CP)	Oct 12, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K042251	BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM	Sep 17, 2004	Substantially Equivalent	Bayer Healthcare, LLC
K041074	BD FACSCANTO WITH BD FACSANTO SOFTWARE	Sep 17, 2004	Substantially Equivalent	Bd Biosciences
K040725	BD FACSCANTO SYSTEM	Sep 10, 2004	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K040026	BD FACS 7-COLOR SETUP BEADS	Sep 10, 2004	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K040073	SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)	Mar 18, 2004	Substantially Equivalent	Sysmex America, Inc.
K032214	MEDONIC CA620/530 HEMATOLOGY ANALYZER	Jan 29, 2004	Substantially Equivalent	Boule Medical AB
K030263	IMMUNICON CELLTRACKS ANALYZER	Nov 24, 2003	Substantially Equivalent	Immunicon Corp.
K032342	COULTER LH 750 HEMATOLOGY ANALYZER	Sep 26, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K032524	ADVIA 60 HEMATOLOGY ANALYZER	Sep 08, 2003	Substantially Equivalent	Bayer Healthcare, LLC
K032039	IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER	Sep 08, 2003	Substantially Equivalent	Sysmex America, Inc.
K032000	COULTER LH 500 HEMATOLOGY ANALYZER	Aug 13, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K032013	COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER	Jul 24, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K030828	TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)	May 21, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K030513	CELL-DYN 1800 SYSTEM	May 12, 2003	Substantially Equivalent	Abbott Laboratories
K030606	COULTER LH 750 BODY FLUIDS APPLICATION	Apr 21, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K030291	COULTER ACT 5DIFF AUTOLOADER (AL)	Apr 17, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K030799	MICROS 60	Apr 08, 2003	Substantially Equivalent	Abx Diagnostics
K030408	CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A	Mar 04, 2003	Substantially Equivalent	Beckman Coulter, Inc.
K030144	MODIFICATION TO PENTRA 60 AND PENTRA 60C+	Jan 31, 2003	Substantially Equivalent	Abx Diagnostics
K024002	PENTRA 80	Jan 03, 2003	Substantially Equivalent	Abx Diagnostics
K022668	ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD	Oct 15, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K022528	IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ	Sep 11, 2002	Substantially Equivalent	Iq Corp.
K022200	PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120	Jul 29, 2002	Substantially Equivalent	Abx Diagnostics
K022161	MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632	Jul 29, 2002	Substantially Equivalent	Beckman Coulter, Inc.
K021241	SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I	Jun 25, 2002	Substantially Equivalent	Sysmex Corporation of America
K020496	HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY	Apr 12, 2002	Substantially Equivalent	Sysmex Corporation of America
K012934	CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE	Sep 28, 2001	Substantially Equivalent	Abbott Laboratories
K012904	ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION	Sep 21, 2001	Substantially Equivalent	Bayer Diagnostics Corp.
K011342	COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632	Jul 09, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K010953	CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY	Jun 06, 2001	Substantially Equivalent	Abbott Laboratories
K010765	COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526	Apr 13, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K003796	ADVIA 120 HEMATOLOGY	Feb 05, 2001	Substantially Equivalent	Bayer Corp.
K003677	ABX PENTRA 60C+ HEMATOLOGY ANALYZER	Dec 26, 2000	Substantially Equivalent	Abx Diagnostics
K002646	ABX MICROS CRP	Oct 26, 2000	Substantially Equivalent	Abx Diagnostics
K000611	STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER	May 18, 2000	Substantially Equivalent	Bd Biosciences
K000897	CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE	May 05, 2000	Substantially Equivalent	Bd Biosciences
K993356	COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES	Apr 20, 2000	Substantially Equivalent	Coulter Corp.
K992875	SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER	Nov 09, 1999	Substantially Equivalent	Sysmex Corp.
K992511	ABX PENTRA 60 HEMATOLOGY ANALYZER	Oct 15, 1999	Substantially Equivalent	Abx Diagnostics
K992444	MODIFICATION OF: CELL-DYN 1200 SYSTEM	Sep 24, 1999	Substantially Equivalent	Abbott Laboratories
K992849	QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM	Sep 23, 1999	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K991839	ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER	Aug 11, 1999	Substantially Equivalent	Abx Diagnostics
K991605	CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION	Jul 09, 1999	Substantially Equivalent	Abbott Laboratories
K991539	EXCELL 22	Jul 01, 1999	Substantially Equivalent	Mwi, Inc.
K991142	CELL-DYN 1200 SYSTEM	Jun 23, 1999	Substantially Equivalent	Abbott Laboratories
K991454	MOUSE IGG1 NEGATIVE CONTROLS	Jun 21, 1999	Substantially Equivalent	Dako Corp.
K991402	DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1	Jun 21, 1999	Substantially Equivalent	Dako Corp.
K990327	RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS	Apr 26, 1999	Substantially Equivalent	Coulter Corp.
K990172	TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA	Apr 13, 1999	Substantially Equivalent	Coulter Corp.
K990352	COULTER AC T DIFF 2 ANALYZER	Apr 01, 1999	Substantially Equivalent	Coulter Corp.
K990311	VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER	Mar 31, 1999	Substantially Equivalent	Abx Diagnostics
K982167	CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1	Nov 09, 1998	Substantially Equivalent	Coulter Corp.
K982166	CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1	Nov 05, 1998	Substantially Equivalent	Coulter Corp.
K983562	MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700	Nov 03, 1998	Substantially Equivalent	Cdc Technologies, Inc.
K982172	CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL	Sep 24, 1998	Substantially Equivalent	Coulter Corp.
K982802	BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)	Sep 22, 1998	Substantially Equivalent	Bayer Corp.
K981568	MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800	Aug 21, 1998	Substantially Equivalent	Cdc Technologies, Inc.
K980635	DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37	Jul 22, 1998	Substantially Equivalent	Dako Corp.
K982231	STATUSFLOW	Jul 20, 1998	Substantially Equivalent	R&D Systems, Inc.
K981342	ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY	Jun 29, 1998	Substantially Equivalent	Abbott Laboratories
K980858	MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION	May 22, 1998	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K980614	ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS	Apr 24, 1998	Substantially Equivalent	Abbott Laboratories
K974360	MULTITEST CD3/CD8/CD45/CD4	Mar 11, 1998	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K973483	FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET	Feb 17, 1998	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K971205	TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES	Dec 01, 1997	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K971110	TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES	Nov 25, 1997	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K970326	TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES	Nov 21, 1997	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K965053	TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES	Nov 21, 1997	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K973634	COULTER AC.T DIFF ANALYZER	Oct 29, 1997	Substantially Equivalent	Coulter Corp.
K970742	TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES	Oct 22, 1997	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K972354	ABBOTT CELL-DYN 3200 SYSTEM	Sep 16, 1997	Substantially Equivalent	Abbott Laboratories
K971736	SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER	Aug 26, 1997	Substantially Equivalent	Sysmex Corp.
K970836	TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS	Aug 26, 1997	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K971152	ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)	Aug 12, 1997	Substantially Equivalent	Abbott Laboratories
K951459	ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE	Jul 14, 1997	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K964974	MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE	Jun 24, 1997	Substantially Equivalent	Dako Corp.
K965232	CALTAG CAL-LYSE	May 14, 1997	Substantially Equivalent	Caltag Laboratories, Inc.
K964988	COULTER AC.T SERIES ANALYZER	Mar 06, 1997	Substantially Equivalent	Coulter Corp.
K960072	SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX	Mar 06, 1997	Substantially Equivalent	Biochem Immunosystems (U.S.), Inc.
K951632	ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)	Mar 06, 1997	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K964754	ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE	Jan 22, 1997	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K963263	TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5	Jan 22, 1997	Substantially Equivalent	Coulter Corp.
K964856	CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION	Jan 17, 1997	Substantially Equivalent	Caltag Laboratories, Inc.
K962768	CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL	Jan 06, 1997	Substantially Equivalent	Coulter Corp.
K962305	CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL	Jan 06, 1997	Substantially Equivalent	Coulter Corp.
K964618	CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1	Dec 23, 1996	Substantially Equivalent	Coulter Corp.
K963963	MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS	Dec 12, 1996	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K963954	CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY	Nov 25, 1996	Substantially Equivalent	Caltag Laboratories, Inc.
K962633	VEGA HEMATOLOGY ANALYZER	Nov 04, 1996	Substantially Equivalent	Abx, Inc.
K961439	ABBOTT CELL-DYN 4000 SYSTEM	Oct 18, 1996	Substantially Equivalent	Abbott Diagnostics
K955715	CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)	Oct 08, 1996	Substantially Equivalent	Abbott Laboratories
K954594	RETICULOCYTE METHOD, RBC INDICES	Aug 23, 1996	Substantially Equivalent	Bayer Corp.
K961278	COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS	Jul 22, 1996	Substantially Equivalent	Coulter Corp.
K961701	MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE	Jul 16, 1996	Substantially Equivalent	Dako Corp.
K961610	R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)	Jul 01, 1996	Substantially Equivalent	R&D Systems, Inc.
K961435	MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE	Jun 14, 1996	Substantially Equivalent	Dako Corp.
K960531	MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE	Jun 14, 1996	Substantially Equivalent	Dako Corp.
K961623	FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS	Jun 07, 1996	Substantially Equivalent	Becton Dickinson Monoclonal Center
K942525	MEDICOUNT DEKA HEMATOLOGY ANALYZER	Jun 05, 1996	Substantially Equivalent	Cea America Corp.
K955673	CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)	May 20, 1996	Substantially Equivalent	Abbott Laboratories
K960887	MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE	May 17, 1996	Substantially Equivalent	Dako Corp.
K960827	QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)	May 17, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K953116	WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER	May 13, 1996	Substantially Equivalent	Intl. Remote Imaging Systems
K951100	ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)	May 13, 1996	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K950625	ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)	May 13, 1996	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K950568	ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)	May 13, 1996	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K950482	ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)	May 10, 1996	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K935720	ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM	May 09, 1996	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K960427	ABBOTT CELL-DYN 3500R SYSTEM	May 02, 1996	Substantially Equivalent	Sequoia Turner Corp.
K954570	ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM	Apr 30, 1996	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K955909	MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE	Mar 28, 1996	Substantially Equivalent	Dako Corp.
K953643	HEMATIL 18 (H-18)	Mar 22, 1996	Substantially Equivalent	Texas Intl. Laboratories, Inc.
K953598	SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS	Mar 11, 1996	Substantially Equivalent	Serono Diagnostics, Inc.
K954688	FLOW-COUNT COULTER FLUOROSPHERES	Feb 29, 1996	Substantially Equivalent	Coulter Corp.
K950342	TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP	Feb 20, 1996	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K946055	TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP	Feb 20, 1996	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K955504	QBC ACCUREAD SYSTEM	Feb 05, 1996	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K945212	MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/	Jan 26, 1996	Substantially Equivalent	Dako Corp.
K951073	CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION	Dec 21, 1995	Substantially Equivalent	Caltag Laboratories, Inc.
K950918	CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION	Dec 21, 1995	Substantially Equivalent	Caltag Laboratories, Inc.
K950917	CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION	Dec 21, 1995	Substantially Equivalent	Caltag Laboratories, Inc.
K950916	CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION	Dec 21, 1995	Substantially Equivalent	Caltag Laboratories, Inc.
K950919	CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION	Dec 20, 1995	Substantially Equivalent	Caltag Laboratories, Inc.
K945756	IMAGN(TM) 2000 SYSTEM	Dec 19, 1995	Substantially Equivalent	Buckman Co., Inc.
K953302	FACS LOADER SYSTEM	Nov 20, 1995	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K933878	ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT	Nov 14, 1995	Substantially Equivalent	Intracel Corp.
K954188	OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL	Nov 03, 1995	Substantially Equivalent	Immunotech Corp.
K946335	OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES	Oct 20, 1995	Substantially Equivalent	Immunotech, Inc.
K951496	CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER	Oct 19, 1995	Substantially Equivalent	Abbott Laboratories
K940003	VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT	Oct 19, 1995	Substantially Equivalent	Buckman Co., Inc.
K953448	ROCHE COBAS MICROS HEMATOLOGY ANALYZER	Oct 13, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K953340	QBC ACCUTUBE	Oct 05, 1995	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K945205	QBC ACCUTUBE	Sep 25, 1995	Substantially Equivalent	Becton Dickinson Diagnostic Instrument Systems
K945678	DATACELL 18MS	Sep 12, 1995	Substantially Equivalent	Danam Electronics
K953498	OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL	Sep 08, 1995	Substantially Equivalent	Immunotech, Inc.
K950742	CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT	Aug 25, 1995	Substantially Equivalent	Coulter Corp.
K950057	TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP	Aug 22, 1995	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K952789	OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES	Aug 14, 1995	Substantially Equivalent	Immunotech Corp.
K950949	COULTER MH025A	Jul 20, 1995	Substantially Equivalent	Coulter Corp.
K952182	OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES	Jul 05, 1995	Substantially Equivalent	Immunotech, Inc.
K944128	CALTAG CD4 R-PE MONOCLONAL ANTIBODY	Jun 20, 1995	Substantially Equivalent	Caltag Laboratories, Inc.
K944127	CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY	Jun 20, 1995	Substantially Equivalent	Caltag Laboratories, Inc.
K944126	CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES	Jun 20, 1995	Substantially Equivalent	Caltag Laboratories, Inc.
K945837	SYSMEX(TM) F-820, 520	Jun 09, 1995	Substantially Equivalent	Sysmex Corp.
K925255	TRAX(TM) CD4 TEST KIT	May 15, 1995	Substantially Equivalent	T Cell Diagnostics, Inc.
K950626	OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES	May 05, 1995	Substantially Equivalent	Immunotech Corp.
K941713	ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)	Apr 26, 1995	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K932532	ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)	Apr 26, 1995	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K932531	ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE	Apr 26, 1995	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K932530	ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)	Apr 26, 1995	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K943967	ONYX	Mar 06, 1995	Substantially Equivalent	Coulter Corp.
K943894	SYSMEX K-4500	Feb 03, 1995	Substantially Equivalent	Sysmex Corp.
K945692	MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)	Jan 25, 1995	Substantially Equivalent	Dako Corp.
K941171	TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)	Dec 14, 1994	Substantially Equivalent	Miles, Inc.
K944253	MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25	Nov 21, 1994	Substantially Equivalent	Dako Corp.
K943284	MONOCLONAL MOUSE ANTI-HUMAN B-CELL	Nov 21, 1994	Substantially Equivalent	Dako Corp.
K942797	MONOCLONAL MOUSE ANTI-HUMAN T-CELL	Nov 10, 1994	Substantially Equivalent	Dako Corp.
K925909	GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION	Oct 27, 1994	Substantially Equivalent	Alicia Diagnostics, Inc.
K925274	AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS	Sep 30, 1994	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K933486	FASCOUNT SYSTME	Sep 09, 1994	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K936023	SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER	May 02, 1994	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K933478	TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11	Nov 22, 1993	Substantially Equivalent	Miles, Inc.
K933475	TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11	Nov 22, 1993	Substantially Equivalent	Miles, Inc.
K923790	FACSORT FLOW CYTOMETER	Sep 01, 1993	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K932030	COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY	Aug 23, 1993	Substantially Equivalent	Coulter Corp.
K930913	COULTER MH015 (DIFFERENTIAL CELL COUNTER)	Aug 23, 1993	Substantially Equivalent	Coulter Corp.
K924587	SIMULTEST CD3/ANTI-HLA-DR	Aug 05, 1993	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K930309	ABBOTT ENCOUNTER(TM)Q	Jul 14, 1993	Substantially Equivalent	Abbott Laboratories
K926124	CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON	Jul 06, 1993	Substantially Equivalent	Coulter Corp.
K930148	TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)	May 11, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K925528	BIOVATION K-MANAGER	Feb 05, 1993	Substantially Equivalent	Biovation, Inc.
K923773	CELLEXIS HEMATOLOGY ANALYZER	Feb 05, 1993	Substantially Equivalent	Technalysis, Inc.
K922745	CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1	Feb 05, 1993	Substantially Equivalent	Coulter Immunology
K922744	CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1	Feb 05, 1993	Substantially Equivalent	Coulter Immunology
K925344	COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA	Jan 21, 1993	Substantially Equivalent	Coulter Corp.
K921279	CD4 CYTOSPHERES KIT	Dec 29, 1992	Substantially Equivalent	Coulter Electronics, Inc.
K923237	TECHNICON H*2	Sep 11, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K922181	COULTER MH009	Aug 17, 1992	Substantially Equivalent	Coulter Electronics, Inc.
K922085	MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM	Jul 28, 1992	Substantially Equivalent	Gen Trak, Inc.
K922084	MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM	Jul 28, 1992	Substantially Equivalent	Gen Trak, Inc.
K922704	COULTER MAXM W/ AUTOLOADER	Jul 27, 1992	Substantially Equivalent	Coulter Electronics, Inc.
K921567	COULTER MH017	Jul 06, 1992	Substantially Equivalent	Coulter Electronics, Inc.
K914848	CD4 MONOCLONAL ANTIBODIES	Jun 19, 1992	Substantially Equivalent	Gen Trak, Inc.
K914846	CD2 MONOCLONAL ANTIBODIES	Jun 19, 1992	Substantially Equivalent	Gen Trak, Inc.
K920949	SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5	May 15, 1992	Substantially Equivalent	Heraeus Kulzer, Inc.
K920544	SYSMEX HEMATOLOGY SYSTEM ACCESSORIES	Apr 29, 1992	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K913192	SIMULTEST(TM) IMK-LYMPHOCYTE	Feb 06, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K915071	DIFFERENTIAL COUNTING BOARD	Jan 17, 1992	Substantially Equivalent	Biovation, Inc.
K914744	SYSMEX NE-1500, MODIFICATION	Dec 30, 1991	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K914014	FACSTRAK FLOW CYTOMETER	Dec 04, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K913305	CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER	Nov 22, 1991	Substantially Equivalent	Unipath , Ltd.
K910473	CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC	Oct 31, 1991	Substantially Equivalent	Coulter Immunology
K901189	MONOCLONAL ANTIBODY ANTI-CD3	Oct 31, 1991	Substantially Equivalent	Sigma Chemical Co.
K901188	MONOCLONAL ANTIBODY ANTI-CD5	Oct 31, 1991	Substantially Equivalent	Sigma Chemical Co.
K901187	MONOCLONAL ANTIBODY ANTI-CD2	Oct 31, 1991	Substantially Equivalent	Sigma Chemical Co.
K901186	MONOCLONAL ANTIBODY ANTI-CD19	Oct 31, 1991	Substantially Equivalent	Sigma Chemical Co.
K913259	NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL	Oct 08, 1991	Substantially Equivalent	Nova Biomedical Corp.
K911626	SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER	Sep 13, 1991	Substantially Equivalent	Serono Baker Diagnostics System
K911793	COULTERCLONE	Jul 09, 1991	Substantially Equivalent	Coulter Immunology
K911385	COULTER(R) MH010	Jun 17, 1991	Substantially Equivalent	Coulter Electronics, Inc.
K904253	ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY	May 20, 1991	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K910834	QBC AUTOREADER	May 07, 1991	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K910283	DANAM DATACELL-18	Apr 12, 1991	Substantially Equivalent	Danam Electronics
K904390	ANTI-HUMAN LEU-2A (CD8) PE	Dec 17, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K904209	SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE	Dec 11, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K903665	CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY	Oct 04, 1990	Substantially Equivalent	Unipath , Ltd.
K900802	ANTI-HUMAN LEU-3A (CD4) FITC	May 15, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K900684	RDW AND MPV INDICES ON HEMAT 12	Apr 16, 1990	Substantially Equivalent	Texas Intl. Laboratories, Inc.
K900276	EXACT ONE(TM) HEMATOLOGY ANALYZER	Apr 16, 1990	Substantially Equivalent	Exact Science, Inc.
K900078	SIMULTEST IMK PLUS(TM)	Apr 02, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K896873	COULTER JT3	Mar 30, 1990	Substantially Equivalent	Coulter Corp.
K900593	TECHNICON H*2(TM) SYSTEM	Mar 14, 1990	Substantially Equivalent	Technicon Instruments Corp.
K893853	COULTER CLONE T8 MONOCLONAL ANTIBODY	Mar 02, 1990	Substantially Equivalent	Coulter Immunology
K893852	COULTER CLONE T4 MONOCLONAL ANTIBODY	Mar 02, 1990	Substantially Equivalent	Coulter Immunology
K894179	COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY	Feb 12, 1990	Substantially Equivalent	Coulter Immunology
K895917	CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI	Dec 29, 1989	Substantially Equivalent	Coulter Immunology
K890349	SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN	Dec 29, 1989	Substantially Equivalent	Becton Dickinson Immunocytometry Systems
K895127	ARGOS	Oct 10, 1989	Substantially Equivalent	Abx, Inc.
K884605	COULTER CLONE MO2	Aug 15, 1989	Substantially Equivalent	Coulter Immunology
K891276	QBC MALARIA SYSTEM	Aug 03, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K893423	QBC III CENTRIFUGAL HEMATOLOGY SYSTEM	Jun 20, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K892205	DANAM VECTOR-8+	Jun 13, 1989	Substantially Equivalent	Danam Electronics
K890491	CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER	Apr 18, 1989	Substantially Equivalent	Abbott Diagnostics
K885028	COULTER 5P CONTROL	Feb 16, 1989	Substantially Equivalent	Coulter Electronics, Inc.
K884020	COULTER CLONE B4 MONOCLONAL ANTIBODY	Feb 03, 1989	Substantially Equivalent	Coulter Immunology
K883753	COULTER CLONE T1 MONOCLONAL ANTIBODY	Feb 03, 1989	Substantially Equivalent	Coulter Immunology
K883710	COULTER CLONE T3 MONOCLONAL ANTIBODY	Feb 03, 1989	Substantially Equivalent	Coulter Immunology
K885093	COULTER STKS	Dec 28, 1988	Substantially Equivalent	Coulter Electronics, Inc.
K884346	CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI	Dec 27, 1988	Substantially Equivalent	Coulter Immunology
K884006	HEMAT 12	Dec 05, 1988	Substantially Equivalent	Texas Intl. Laboratories, Inc.
K883997	SYSMEX NE-8000	Dec 05, 1988	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K883177	H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER	Nov 30, 1988	Substantially Equivalent	Texas Intl. Laboratories, Inc.
K882557	COULTER CLONE B1 MONOCLONAL ANTIBODY	Sep 14, 1988	Substantially Equivalent	Coulter Immunology
K882612	SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER	Sep 07, 1988	Substantially Equivalent	Baker Instructions Corp.
K882579	HEMATRAK(R) MODEL 590	Sep 07, 1988	Substantially Equivalent	Priority Service Systems
K882370	SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER	Aug 25, 1988	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K880616	MINOS AUTOMATIC CELL COUNTER	May 02, 1988	Substantially Equivalent	Abx, Inc.
K875346	AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)	Apr 07, 1988	Substantially Equivalent	Contraves Medical Instruments, Inc.
K880507	COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER	Apr 04, 1988	Substantially Equivalent	Coulter Electronics, Inc.
K875047	COULTER CLONE T11 MONOCLONAL ANTIBODY	Mar 09, 1988	Substantially Equivalent	Coulter Electronics, Inc.
K874838	COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.	Feb 19, 1988	Substantially Equivalent	Coulter Electronics, Inc.
K874763	CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER	Feb 18, 1988	Substantially Equivalent	Instrumentation Laboratory CO
K874147	QBC BLOOD BANK SYSTEM	Jan 11, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K874427	QBC SYSTEM HEMOGLOBIN	Jan 05, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K873734	SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER	Nov 25, 1987	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K873256	MICRO-COUNT DIFFHE	Nov 06, 1987	Substantially Equivalent	Toni Diagnostics, Inc.
K872761	CELL-DYN 610 HEMATOLOGY ANALYZER	Aug 06, 1987	Substantially Equivalent	Abbott Diagnostics
K864579	MINOS AUTOMATIC CELL COUNTER	Jul 16, 1987	Substantially Equivalent	Abx, Inc.
K871837	COULTER COUNTER MODEL S-PLUS STKR	Jul 02, 1987	Substantially Equivalent	Coulter Electronics, Inc.
K871600	SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.	Jun 24, 1987	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K870233	CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER	Mar 17, 1987	Substantially Equivalent	Abbott Diagnostics
K855117	SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM	Feb 24, 1986	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K855116	SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM	Feb 24, 1986	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K853027	TECHNICON H*1 SYSTEM (MPXI)	Feb 05, 1986	Substantially Equivalent	Technicon Instruments Corp.
K853029	TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA	Jan 24, 1986	Substantially Equivalent	Technicon Instruments Corp.
K852988	TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.	Jan 21, 1986	Substantially Equivalent	Technicon Instruments Corp.
K854368	CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER	Jan 01, 1986	Substantially Equivalent	Abbott Diagnostics
K854242	QBC CENTRIFUGAL HEMATOLOGY SYSTEM	Jan 01, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K853304	21 HEMATOLOGY REAGENTS	Nov 12, 1985	Substantially Equivalent	In Vitro Diagnostics, Inc.
K852371	CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY	Sep 17, 1985	Substantially Equivalent	Abbott Diagnostics
K850354	SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS	May 20, 1985	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K844910	SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -	Apr 01, 1985	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K844645	QBC CENTRIFUGAL HEMATOLOGY ANALYZER	Mar 05, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K841852	AUTOLYZER 800	Sep 05, 1984	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K842636	TECHNICON H*1 SYSTEM	Jul 27, 1984	Substantially Equivalent	Technicon Instruments Corp.
K840195	FACS ANALYZER	Apr 30, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K833618	ORTHO ELT-8/DS HEMATOLOGY ANALYZER	Jan 13, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K833600	COULTER COUNTER MODEL S-PLUS V	Jan 10, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K831271	ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG	Jul 26, 1983	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K823355	COULTER-COUNTER #S PLUS IV & LYSE S +D	Dec 28, 1982	Substantially Equivalent	Coulter Electronics, Inc.
K821186	PENETRAK TM	Jun 25, 1982	Substantially Equivalent	Syva Co.
K803219	ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.	Jan 21, 1981	Substantially Equivalent	Abbott Laboratories
K800533	ADD OF RETICULOCYTE COUNT/CAPABILITIES	Apr 04, 1980	Substantially Equivalent	Abbott Laboratories
K800121	TECHNICON C/90 SYSTEM	Feb 05, 1980	Substantially Equivalent	Technicon Instruments Corp.
K791903	COULTER DIFF3 SYS. (COULTER #7400003)	Oct 30, 1979	Substantially Equivalent	Coulter Electronics, Inc.
K791041	HEMATRAK ABNORMAL RECOGNITION	Sep 04, 1979	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K791108	CONTEXT FILTER	Jul 17, 1979	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K790816	HEMATRAK MODEL 480	Jul 17, 1979	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K782050	PRINTER, TEK PRO TEK TALLY II	Jan 03, 1979	Substantially Equivalent	Tekpro
K780577	PLATELETS/CU MM	May 19, 1978	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K761207	HEMATRAK RBC MORPHOLOGY	Oct 18, 1977	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K770244	AUTO DIFFERENTIAL CELL COUNTER SYSTEM	Aug 04, 1977	Substantially Equivalent	Abbott Laboratories
K770680	HEMATRAK	Jul 01, 1977	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K770550	ATYPIA PROFILE MONITOR	Jun 17, 1977	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K770701	HEMATRAK MODEL 125	Jun 03, 1977	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K770869	ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION	Jun 02, 1977	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.
K761208	HEMATRAK MATURITY PROFILE OPTION	Feb 28, 1977	Substantially Equivalent	Geometric Data, Div. Smithkline Corp.