Product Code: GKL FDA class 2 21 CFR 864.5200

Counter, Cell, Automated (Particle Counter)

Hematology

Counter, Cell, Automated (Particle Counter) (product code GKL) is an automated hematology instrument that uses electrical impedance or optical detection to enumerate and size blood cells and other particles in suspension, forming the core technology of modern complete blood count (CBC) analyzers. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.5200 in the Hematology specialty (HE), it is eligible for third-party review.

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510(k)s

130

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GKL
Device Class: FDA class 2
Regulation Number: 864.5200
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 130 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K152776	Glocyte Automated Cell Counter System	May 27, 2016	Substantially Equivalent	Advanced Instruments, Inc.
K091539	IQ 200 URINE ANALIZER BODY FLUIDS MODULE	Aug 31, 2010	Substantially Equivalent	Iris Diagnostics
K071652	HEMOCUE WBC SYSTEM	Oct 25, 2007	Substantially Equivalent	Hemocue AB
K051693	MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM	Dec 07, 2005	Substantially Equivalent	Bayer Healthcare, LLC
K050235	IQ 200 URINE ANALYZER BODY FLUIDS MODULE	Mar 23, 2005	Substantially Equivalent	Iris International, Inc.
K032677	SYSMEX POCH-100I	Feb 11, 2004	Substantially Equivalent	Sysmex America, Inc.
K022331	ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD	Sep 11, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K001683	SYSMEX R-500	Aug 21, 2000	Substantially Equivalent	Sysmex Corporation of America
K991070	COULTER Z2 ANALYZER	May 11, 1999	Substantially Equivalent	Coulter Corp.
K981950	SYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500	Nov 03, 1998	Substantially Equivalent	Sysmex Corp.
K981761	SYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZER	Aug 14, 1998	Substantially Equivalent	Sysmex Corp.
K971998	ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM	Aug 29, 1997	Substantially Equivalent	Bayer Corp.
K964375	SYSMEX SE/RAM-1	Mar 13, 1997	Substantially Equivalent	Sysmex Corp.
K962988	COULTER GEN-S SYSTEM	Oct 30, 1996	Substantially Equivalent	Coulter Corp.
K954607	RETICULOCYTE METHOD	Aug 30, 1996	Substantially Equivalent	Bayer Corp.
K954006	YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY	Mar 12, 1996	Substantially Equivalent	Intl. Remote Imaging Systems
K952308	COULTER Z 1	Oct 06, 1995	Substantially Equivalent	Coulter Corp.
K934539	THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY	Mar 30, 1994	Substantially Equivalent	Intl. Remote Imaging Systems
K930685	TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)	Jun 22, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K923121	QBC HEMACAN HEMATOLOGY SYSTEM	Sep 22, 1992	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K920719	IVOS ANALYZER	Jun 29, 1992	Substantially Equivalent	Hamilton Thorne Research
K914256	YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU	May 01, 1992	Substantially Equivalent	Intl. Remote Imaging Systems
K912494	SYSMEX(TM) R-3000 AUTOMATED RETICULOCYTE ANALYZER	Sep 10, 1991	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K911173	SYSMEX F-310	Jul 26, 1991	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K911172	SYSMEX F-610	Jul 26, 1991	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K910849	SYSMEX F-810	Jul 26, 1991	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K910679	GENESIS I AUTOMATED CELL COUNTER	May 07, 1991	Substantially Equivalent	Alicia Diagnostics, Inc.
K894539	SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER	Sep 26, 1989	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K885332	COULTER FLOW RETICULOCYTE REAGENT	Feb 22, 1989	Substantially Equivalent	Coulter Electronics, Inc.
K884618	NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS	Jan 24, 1989	Substantially Equivalent	Nova Biomedical Corp.
K885132	FACSMATE SAMPLE HANDLING DEVICE	Dec 28, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K884471	KVM BLOOD CELL COUNTER	Dec 27, 1988	Substantially Equivalent	Kvm Instruments, Inc.
K880636	RETICCOUNT SOFTWARE	Mar 21, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K874320	CELLECT LABTRAK SOFTWARE	Jan 27, 1988	Substantially Equivalent	Instrumentation Laboratory CO
K872145	CELLSOFT(TM)-CASA (SERIES 1000,2000 & 3000)	Nov 13, 1987	Substantially Equivalent	Cryo Corp.
K873271	DIGICELL 300 SYSTEM	Nov 06, 1987	Substantially Equivalent	Contraves Medical Instruments, Inc.
K873252	DIGICELL 500	Nov 06, 1987	Substantially Equivalent	Contraves Medical Instruments, Inc.
K873172	HAMILTON-THORN MOTILITY ANALYZER HTM-2000	Nov 06, 1987	Substantially Equivalent	Hamilton Thorne Research
K872166	FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT	Sep 30, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K871830	NAPSAC(TM)	Sep 09, 1987	Substantially Equivalent	Beecher Medical Diagnostic Instrumentation
K873103	TECHNICON H*1 JR.(TM) SYSTEM	Aug 28, 1987	Substantially Equivalent	Technicon Instruments Corp.
K870603	SYSTEM 9000 AUTOMATED CELL COUNTER	Mar 31, 1987	Substantially Equivalent	Baker Instructions Corp.
K863332	ATAC 4300 HEMATOLOGY CELL COUNTER	Sep 29, 1986	Substantially Equivalent	Turpen Laboratory Systems, Inc.
K863291	IL CELLECT 8	Sep 04, 1986	Substantially Equivalent	Instrumentation Laboratory CO
K863290	IL CELLECT 7	Sep 04, 1986	Substantially Equivalent	Instrumentation Laboratory CO
K863085	COULTER COUNTER MODEL T-540	Sep 04, 1986	Substantially Equivalent	Coulter Electronics, Inc.
K863084	COULTER COUNTER MODEL T-890	Sep 04, 1986	Substantially Equivalent	Coulter Electronics, Inc.
K862374	CELLECT 8E AUTOMATED BLOOD CELL COUNTERS	Sep 04, 1986	Substantially Equivalent	Instrumentation Laboratory CO
K861780	COULTER COUNTER MODEL S PLUS JUNIOR	Aug 06, 1986	Substantially Equivalent	Coulter Electronics, Inc.
K860586	PHA-2 CONVERSION PROGRAM FOR PLATELET ANALYSIS	May 07, 1986	Substantially Equivalent	Diagnostic Technology, Inc.
K860166	PICOSCALE BLOOD CELL COUNTER, MODEL PS-5	Apr 04, 1986	Substantially Equivalent	Diagnostic Technology, Inc.
K854678	ERMA PC-602 PC-603 BLOOD CELL COUNTER	Feb 24, 1986	Substantially Equivalent	Future Impex Corp.
K854677	ERMA PC-604 BLOOD CELL COUNTER	Feb 24, 1986	Substantially Equivalent	Future Impex Corp.
K853030	TECHNICON H*1 SYSTEM (HDW)	Feb 05, 1986	Substantially Equivalent	Technicon Instruments Corp.
K853722	PLT-4 PLATELET ANALYZER	Jan 17, 1986	Substantially Equivalent	Texas Intl. Laboratories, Inc.
K854114	COULTER COUNTER MODEL T-660	Nov 05, 1985	Substantially Equivalent	Coulter Electronics, Inc.
K853036	PICOSCALE LABORSCALE, #PSL-1 & ANALYSER, #PSA-1	Nov 05, 1985	Substantially Equivalent	Diagnostic Technology, Inc.
K853429	COULTER COUNTER MODEL M5	Oct 10, 1985	Substantially Equivalent	Coulter Electronics, Inc.
K851943	COULTER VOLUME ADAPTER	Aug 30, 1985	Substantially Equivalent	Coulter Electronics, Inc.
K851736	COULTER CHANNELYZER 256	Jul 30, 1985	Substantially Equivalent	Coulter Electronics, Inc.
K850171	SYSMEX E-3000, FULLY AUTOMATED HEMATOLOGY SYS	May 13, 1985	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K850386	SYSTEM 8000 CELL COUNTER	May 02, 1985	Substantially Equivalent	Baker Instructions Corp.
K845019	CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER	Mar 26, 1985	Substantially Equivalent	Abbott Diagnostics
K841803	A1 SYSTEME 8201/2	Feb 25, 1985	Substantially Equivalent	Med USA
K843303	COULTER COUNTER MODEL M4	Dec 05, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K843164	COULTER COUNTER MODEL ZM	Nov 13, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K844042	BLOOD DILUTION VIAL	Oct 23, 1984	Substantially Equivalent	American Scientific Products
K842140	PICOSCAL BLOOD CELL COUNTER PS-4	Aug 16, 1984	Substantially Equivalent	Diagnostic Technology, Inc.
K842346	COULTER AUTOMATIC SAMPLE HANDLER	Jul 27, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K840649	DANAM ELEC. SA-1000	Jul 19, 1984	Substantially Equivalent	Danam Electronics
K841504	QUICK-COUNT PLUS 2	Jun 11, 1984	Substantially Equivalent	Seragen Diagnostics, Inc.
K840658	QBC CENTRIFUGAL HEMATOLOGY ANALYZ	Apr 17, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K840170	CELL-DYN 100 WHOLE BLOOD PLATELET	Mar 02, 1984	Substantially Equivalent	Abbott Diagnostics
K834568	COULTER COUNTER M2	Feb 10, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K834372	PHA-1 PROGRAMMABLE HEMATOLOGY ANALYZ	Feb 10, 1984	Substantially Equivalent	Diagnostic Technology, Inc.
K834026	RDW PARAMETER FOR THE TECHNICON H6000	Jan 30, 1984	Substantially Equivalent	Technicon Instruments Corp.
K833971	QUICK-COUNT	Jan 30, 1984	Substantially Equivalent	Seragen Diagnostics, Inc.
K832890	HEMACOMP 7 OR HEMATIL 7	Oct 19, 1983	Substantially Equivalent	Texas Intl. Laboratories, Inc.
K832643	CELL-DYN 900 HEMATOLOGY ANALYZER	Sep 26, 1983	Substantially Equivalent	Abbott Diagnostics
K832627	TECHNICON H6000 SYSTEM	Sep 12, 1983	Substantially Equivalent	Technicon Instruments Corp.
K832420	FACS ANALYZER	Sep 01, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K832038	CELL-DYN 300 HEMATOLOGY ANALYZER	Jul 18, 1983	Substantially Equivalent	Abbott Diagnostics
K831368	CELL-DYN 400 HEMOTOLOGY ANALYZER	Jul 18, 1983	Substantially Equivalent	Abbott Diagnostics
K830507	SYSMEX CC-170	May 13, 1983	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K830508	SYSMEX CC-180	May 09, 1983	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K830506	SYSMEX CC-150	May 09, 1983	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K830505	SYSMEX CC-130	May 09, 1983	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K830451	QBC CENTRIFUGAL HEMATOLOGY SYS	Apr 27, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K823886	PROFILE 750 BLOOD CELL COUNTER	Mar 01, 1983	Substantially Equivalent	Mallinckrodt Critical Care
K823344	HEMATOLOGY ANALYZER	Dec 28, 1982	Substantially Equivalent	Abbott Diagnostics
K822758	SYSMEX PDA-410 (PARTICLE DISTRIB. ANALY	Oct 18, 1982	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K821575	SYSMEX CC-800	Jul 02, 1982	Substantially Equivalent	Sysmex/Toa Medical Electronics, Inc.
K821238	CC-700 SEVEN PARAMETER, AUTOMATED HEMAA	May 28, 1982	Substantially Equivalent	Dysmex
K812031	LPC II	Aug 12, 1981	Substantially Equivalent	Labtronix Corp.
K811978	TECHNICON H6000 (90/HR) HEMATOLOGY SYS	Aug 12, 1981	Substantially Equivalent	Technicon Instruments Corp.
K803071	PLA-MATE	Jul 24, 1981	Substantially Equivalent	Labex, Inc.
K803218	CELL DYN 800 HEMATOLOGY ANALYZER	Jun 09, 1981	Substantially Equivalent	Abbott Diagnostics
K803128	SERIES 810 PLATELET ANALYZER	Apr 03, 1981	Substantially Equivalent	J.T. Baker Chemical Co.
K802636	PLATELET COUNTING KIT	Dec 11, 1980	Substantially Equivalent	Streck Laboratories, Inc.
K802094	ORTHO SPECTRUM	Oct 10, 1980	Substantially Equivalent	Ortho Instruments
K802208	LEUKOCYTE VOL. ANALYSIS APPARATUS	Sep 17, 1980	Substantially Equivalent	Coulter Electronics, Inc.
K801545	ORTHO AUTOMATED CELL COUNTER	Sep 09, 1980	Substantially Equivalent	Ortho Instruments
K801155	TECHNICON H6000 HEMATOLOGY SYSTEM	Jun 09, 1980	Substantially Equivalent	Technicon Instruments Corp.
K800346	HEMOSAFE	Apr 16, 1980	Substantially Equivalent	Med Lab Systems, Inc.
K792668	COULTER COUNTER-BLOOD CELL COUNTER	Jan 29, 1980	Substantially Equivalent	Coulter Electronics, Inc.
K792537	COULTER COUNTER MODEL S PLUS	Jan 29, 1980	Substantially Equivalent	Coulter Electronics, Inc.
K791867	ROYCO MODEL 921 CELL COUNTER	Nov 05, 1979	Substantially Equivalent	Royco Instruments
K790026	ANALYZER, MODEL CC-720	Feb 08, 1979	Substantially Equivalent	Sysmex Corp.
K782102	HYCEL COUNTER 211	Jan 03, 1979	Substantially Equivalent	Hycel, Inc.
K782101	HYCEL COUNTER 222	Jan 03, 1979	Substantially Equivalent	Hycel, Inc.
K782100	HYCEL COUNTER 333	Jan 03, 1979	Substantially Equivalent	Hycel, Inc.
K781562	HEMACHECK	Nov 15, 1978	Substantially Equivalent	Vickers America Medical Corp.
K781628	HEMO-W SYSTEM	Oct 27, 1978	Substantially Equivalent	Coulter Electronics, Inc.
K781146	HEMAC LASER HEMATOLOGY SYSTEM	Sep 14, 1978	Substantially Equivalent	Ortho Instruments
K780911	SYSMEX PLATELET COUNTER, PL-110	Jun 28, 1978	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K780910	SYSTEM AUTO. BLOOD CELL COUNTER CC-110	Jun 28, 1978	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K780909	SYSMEX AUTO. BLOOD CELL COUNTER, CC-120	Jun 28, 1978	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K780224	MICROCELL COUNTER MODEL CC-108	May 19, 1978	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K771512	COUNTER MODEL S PLUS BLOOD CELL COUNTER	Nov 09, 1977	Substantially Equivalent	Coulter Electronics, Inc.
K771728	AUTO. LEUCOCYTE DIFFER. ANALYZER D/90	Nov 07, 1977	Substantially Equivalent	Technicon Instruments Corp.
K771790	DETECTOTERGE AZIDE FREE	Oct 07, 1977	Substantially Equivalent	J.T. Baker Chemical Co.
K771353	PLATELET COUNTER & HEMATOCRIT ACCES.	Aug 10, 1977	Substantially Equivalent	Hycel, Inc.
K771107	COUNTER 700 & HC-700 HEMO 0 REF.	Jul 11, 1977	Substantially Equivalent	Hycel, Inc.
K770666	HEMALOG 8/90	May 06, 1977	Substantially Equivalent	Technicon Instruments Corp.
K770385	LATELET DETERMIN. KIT, CAT NO. 2521	Apr 08, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K761289	ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)	Mar 28, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K770034	COUNTER, BLOOD CELL & HEMATOCRIT	Feb 16, 1977	Substantially Equivalent	Mallinckrodt Critical Care
K760765	WHOLE BLOOD PLATELET COUNTER -2510	Dec 30, 1976	Substantially Equivalent	Clay Adams, Div. Becton Dickinson & Co.
K760582	HA/3 HEMATOLOGY ANALYZER	Nov 11, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760581	HA/5 HEMATOLOGY ANALYZER	Nov 09, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic