Product Code: JPK FDA class 2 21 CFR 864.8625

Mixture, Hematology Quality Control

Hematology

The Mixture, Hematology Quality Control is a hematology laboratory product consisting of prepared control materials used to verify the accuracy, precision, and performance of hematology analyzers and related instruments as part of laboratory quality assurance programs. This device is FDA Class 2, indicating moderate risk; it does not require a 510(k) under its current submission type but is subject to general and special controls. It carries product code JPK and is regulated under 21 CFR 864.8625, within the Hematology medical specialty.

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510(k)s

192

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JPK
Device Class: FDA class 2
Regulation Number: 864.8625
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 192 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K160590	XN CHECK	Dec 22, 2016	Substantially Equivalent	Streck
K160588	XN CHECK BF	Dec 22, 2016	Substantially Equivalent	Streck
K160586	XN-L CHECK	Dec 22, 2016	Substantially Equivalent	Streck
K160606	BC-5D Hematology Control	Sep 01, 2016	Substantially Equivalent	R&D Systems, Inc.
K141964	XN CHECK	Dec 05, 2014	Substantially Equivalent	Streck
K141957	XN CHECK BF	Dec 05, 2014	Substantially Equivalent	Streck
K130962	R&D 5D RETIC HEMATOLOGY CONTROL	Jul 24, 2013	Substantially Equivalent	R&D Systems, Inc.
K120744	XN CHECK BF	Oct 19, 2012	Substantially Equivalent	Streck
K120742	XN CHECK	Oct 19, 2012	Substantially Equivalent	Streck
K101578	R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL	Apr 28, 2011	Substantially Equivalent	R&D Systems, Inc.
K100790	COULTER LIN-X LINEARITY CONTROL, MODEL A81196	Dec 21, 2010	Substantially Equivalent	Beckman Coulter, Inc.
K100607	COULTER 4C-EX 300 CELL CONTROL	Nov 18, 2010	Substantially Equivalent	Beckman Coulter, Inc.
K091303	LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV	Aug 02, 2010	Substantially Equivalent	Bio-Rad Laboratories
K100050	R & D SYSTEMS XERET HEMATOLOGY CONTROL	Jan 29, 2010	Substantially Equivalent	R&D Systems, Inc.
K091433	R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL	Oct 28, 2009	Substantially Equivalent	R&D Systems, Inc.
K090201	UA-CELLULAR FOR IQ	Mar 27, 2009	Substantially Equivalent	Streck
K082162	COULTER BODY FLUID CONTROL	Feb 03, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K081822	COULTER 6C CELL CONTROL, MODELS 628027 & A59925	Jan 21, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K081641	COULTER LIN-X LINEARITY CONTROL	Jan 16, 2009	Substantially Equivalent	Beckman Coulter, Inc.
K073178	HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004	Dec 27, 2007	Substantially Equivalent	R&D Systems, Inc.
K072846	CSF AUTOMATED CONTROL, MODELS CSF001, CSF003	Nov 26, 2007	Substantially Equivalent	R&D Systems, Inc.
K072268	HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S	Nov 20, 2007	Substantially Equivalent	R&D Systems, Inc.
K072096	CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04	Aug 20, 2007	Substantially Equivalent	R&D Systems, Inc.
K070199	RETIC-CHEX LINEARITY FOR BC	Feb 23, 2007	Substantially Equivalent	Streck
K063218	E-CHECK (XE)	Dec 14, 2006	Substantially Equivalent	Streck
K061511	R&D CBC-3D + CRP HEMATOLOGY CONTROL	Jul 10, 2006	Substantially Equivalent	R&D Systems, Inc.
K061320	R&D LH-NRBC HEMATOLOGY CONTROL	Jun 02, 2006	Substantially Equivalent	R&D Systems, Inc.
K061064	COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503	May 17, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K060464	COULTER 5C CELL CONTROL	Mar 28, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K053362	CELL-CHEX AUTO	Jan 13, 2006	Substantially Equivalent	Streck
K051706	IQ BODY FLUIDS CONTROL	Aug 17, 2005	Substantially Equivalent	Streck
K051339	R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL	Jul 12, 2005	Substantially Equivalent	R&D Systems, Inc.
K050721	ABX ERYTROL	Jun 01, 2005	Substantially Equivalent	Horiba Abx
K042836	LIQUICHEK RETICULOCYTE CONTROL (A)	Nov 05, 2004	Substantially Equivalent	Bio-Rad
K042587	RETIC-CHEX FOR CELL-DYN	Oct 19, 2004	Substantially Equivalent	Streck Laboratories, Inc.
K042336	METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK	Oct 14, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K042094	R&D CBC-XE HEMATOLOGY CONTROL	Sep 01, 2004	Substantially Equivalent	R&D Systems, Inc.
K041457	LIQUICHEK HEMATOLOGY CONTROL (A)	Jun 28, 2004	Substantially Equivalent	Bio-Rad
K024173	CDS 3-PD HEMATOLOGY CONTROLS	Jan 14, 2003	Substantially Equivalent	Clinical Diagnostic Solutions, Inc.
K022968	ADVIA TESTPOINT CSF CONTROL	Sep 24, 2002	Substantially Equivalent	Bayer Diagnostics Corp.
K021922	MODIFICATION TO PARA 5X	Jun 25, 2002	Substantially Equivalent	Streck Laboratories, Inc.
K020229	R & D BODY FLUID CONTROL	Feb 06, 2002	Substantially Equivalent	R&D Systems, Inc.
K013898	R&D RET-LINE KIT	Jan 22, 2002	Substantially Equivalent	R&D Systems, Inc.
K013842	IMMUNO-TROL LOW CELLS	Dec 13, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K011410	PARA 5X	Jun 26, 2001	Substantially Equivalent	Streck Laboratories, Inc.
K010470	R & D 4K RETIC	May 11, 2001	Substantially Equivalent	R&D Systems, Inc.
K010461	ADVIA RETIC PLUS	Apr 03, 2001	Substantially Equivalent	R&D Systems, Inc.
K010598	SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL	Mar 23, 2001	Substantially Equivalent	Quantimetrix Corp.
K010409	CBC-SF	Mar 16, 2001	Substantially Equivalent	R&D Systems, Inc.
K010066	5C-ES CELL CONTROL, MODELS 7547191, 7547192	Feb 07, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K010064	4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190	Feb 07, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K003874	CBC-4K HEMATOLOGY CONTROL	Jan 12, 2001	Substantially Equivalent	R&D Systems, Inc.
K003534	PENTRA 5D	Dec 01, 2000	Substantially Equivalent	R&D Systems, Inc.
K003208	R & D 3K RETIC	Nov 07, 2000	Substantially Equivalent	R&D Systems, Inc.
K002511	FETALTROL	Sep 11, 2000	Substantially Equivalent	Trillium Diagnostics, LLC
K000115	RETIC CHEX LINEARITY	Mar 27, 2000	Substantially Equivalent	Streck Laboratories, Inc.
K993496	RETIC-QUINOX	Nov 30, 1999	Substantially Equivalent	Hematronix, Inc.
K991876	SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE	Jun 17, 1999	Substantially Equivalent	R&D Systems, Inc.
K984216	IMMUNO-TROL CONTROL CELLS	Mar 16, 1999	Substantially Equivalent	Coulter Corp.
K983032	CBC-5D HEMATOLOGY CONTROL	Feb 17, 1999	Substantially Equivalent	R&D Systems, Inc.
K984099	QBC CENTRIFUGAL HEMATOLOGY CONTROL	Dec 10, 1998	Substantially Equivalent	R&D Systems, Inc.
K972172	ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION	Jul 24, 1997	Substantially Equivalent	R&D Systems, Inc.
K972170	ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION	Jul 24, 1997	Substantially Equivalent	R&D Systems, Inc.
K971469	COULTER ACT TRON CELL CONTROL	Jun 30, 1997	Substantially Equivalent	Coulter Corp.
K970331	CBC-4K HEMATOLOGY CONTROL	Apr 16, 1997	Substantially Equivalent	R&D Systems, Inc.
K961673	R&D RETIC-PG HEMATOLOGY CONTROL	Jul 15, 1996	Substantially Equivalent	R&D Systems, Inc.
K960557	CALIBRATION VERIFICATION ASSESSMENT (CVA)	Apr 03, 1996	Substantially Equivalent	Streck Laboratories, Inc.
K960471	TRI-COUNT 20	Mar 20, 1996	Substantially Equivalent	Hematronix, Inc.
K960005	TRI-COURT 20-T	Mar 19, 1996	Substantially Equivalent	Hematronix, Inc.
K955334	COULTER LINEARITY CONTROL	Feb 08, 1996	Substantially Equivalent	Coulter Corp.
K955016	4C PLUS COULTER CELL CONTROL	Jan 30, 1996	Substantially Equivalent	Coulter Corp.
K954137	QBC CENTRIFUGAL HEMATOLOGY CONTROL	Oct 06, 1995	Substantially Equivalent	R&D Systems, Inc.
K952720	AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II	Sep 20, 1995	Substantially Equivalent	Aalto Scientific, Ltd.
K952245	SF-CHECK	Sep 01, 1995	Substantially Equivalent	Streck Laboratories, Inc.
K941965	EZ-RANGE	Apr 25, 1995	Substantially Equivalent	Hematronix, Inc.
K943336	RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE	Dec 12, 1994	Substantially Equivalent	R&D Systems, Inc.
K943335	RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE	Dec 12, 1994	Substantially Equivalent	R&D Systems, Inc.
K944751	COULTER FLOW SET	Dec 08, 1994	Substantially Equivalent	Coulter Corp.
K942822	CBC-LINE HEMATOLOGY LINEARITY CONTROL	Oct 07, 1994	Substantially Equivalent	R&D Systems, Inc.
K935196	PARA 5 DIFF	Apr 05, 1994	Substantially Equivalent	Streck Laboratories, Inc.
K940089	CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE	Mar 22, 1994	Substantially Equivalent	R&D Systems, Inc.
K940181	SE-CHECK	Mar 09, 1994	Substantially Equivalent	Streck Laboratories, Inc.
K935343	CENTRIFIQ BLOOD CONTROL	Jan 27, 1994	Substantially Equivalent	Hematronix, Inc.
K931947	CHECKPOINT	Jun 18, 1993	Substantially Equivalent	Medical Specialties, Inc.
K930119	COULTER RETIC-C CELL CONTROL	Apr 05, 1993	Substantially Equivalent	Coulter Electronics, Inc.
K923971	QC-CHEX	Nov 16, 1992	Substantially Equivalent	Streck Laboratories, Inc.
K914099	GAS TRAK CONNECT BLOOD GAS CONTROL	Dec 18, 1991	Substantially Equivalent	Biochemical Sciences, Inc.
K913879	CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE	Nov 27, 1991	Substantially Equivalent	R&D Systems, Inc.
K912133	PX COULTER(R) CELL CONTROL	Jul 17, 1991	Substantially Equivalent	Coulter Electronics, Inc.
K905524	RETIC-CHEX	Feb 20, 1991	Substantially Equivalent	Streck Laboratories, Inc.
K904637	QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE	Oct 29, 1990	Substantially Equivalent	R&D Systems, Inc.
K904461	METER TRAX	Oct 26, 1990	Substantially Equivalent	Hematronix, Inc.
K904464	CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED	Oct 23, 1990	Substantially Equivalent	R&D Systems, Inc.
K900017	REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210)	Jan 29, 1990	Substantially Equivalent	Helena Laboratories
K893895	HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL	Jul 25, 1989	Substantially Equivalent	Intercare Diagnostics, Inc.
K884266	PH BLOOD GAS CONTROL PRODUCTS	May 16, 1989	Substantially Equivalent	Alko Diagnostic Corp.
K890767	NE-CHECK	Mar 23, 1989	Substantially Equivalent	Streck Laboratories, Inc.
K890749	CBC-TECH (TM) HEMATOLOGY CONTROL/MULTIPLE	Feb 27, 1989	Substantially Equivalent	R&D Systems, Inc.
K880270	MSI-DIFF PLUS	Mar 01, 1988	Substantially Equivalent	Medical Specialties, Inc.
K873354	QBC VENOUS BLOOD CONTROL/MULTIPLE	Sep 29, 1987	Substantially Equivalent	R&D Systems, Inc.
K871067	MSI HEMATOLOGY CONTROL +	Mar 25, 1987	Substantially Equivalent	Medical Specialties, Inc.
K863224	HEMATALL-C PLUS HEMATOLOGY CONTROLS	Oct 29, 1986	Substantially Equivalent	Fisher Scientific Co., LLC
K862318	FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR	Jul 10, 1986	Substantially Equivalent	Fisher Scientific Co., LLC
K862186	LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II	Jul 01, 1986	Substantially Equivalent	Bio-Rad
K860751	VON WILLEBRAND FAC. DEFIC. ABNORMAL CONTROL PLASMA	Mar 18, 1986	Substantially Equivalent	Bio/Data Corp.
K854353	PLATELET-TROL II	Nov 26, 1985	Substantially Equivalent	R&D Systems, Inc.
K852992	PARA CHECK (AKA EIGHT CHECK-C)	Oct 10, 1985	Substantially Equivalent	Streck Laboratories, Inc.
K853776	MSI-HB HEMOGLOBIN CONTROL	Sep 19, 1985	Substantially Equivalent	Medical Specialties, Inc.
K852372	CELL-DYN BRAND HEMATOLOGY REAGENTS	Sep 03, 1985	Substantially Equivalent	Abbott Diagnostics
K851663	QUICK-COUNT HEMATOLOGY CONTROLS	Jul 23, 1985	Substantially Equivalent	Seragen Diagnostics, Inc.
K851375	TRI-COUNT	Jul 12, 1985	Substantially Equivalent	Hematology Marketing Assoc.
K850755	CBC-PLT-4/MULTIPLE WHOLE BLOOD HEMATOLOGY CONTROL	May 13, 1985	Substantially Equivalent	R&D Systems, Inc.
K850250	TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH	Apr 01, 1985	Substantially Equivalent	Technicon Instruments Corp.
K844928	QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE	Mar 22, 1985	Substantially Equivalent	Bhp Diagnostix, Inc.
K844927	QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS	Mar 22, 1985	Substantially Equivalent	Bhp Diagnostix, Inc.
K844897	HEMATOLOGY CONTROL UNI-CELL 5, UNI-CELL 7 & 8	Mar 22, 1985	Substantially Equivalent	Medical Specialties Laboratories
K843805	COULTER CHECK SAMPLE UNASSAYED HEMATOLOG	Dec 17, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K843485	TRI-COUNT LASER	Dec 12, 1984	Substantially Equivalent	Hematology Marketing Assoc.
K841809	COUNT-A-PART PLUS	Nov 30, 1984	Substantially Equivalent	Diagnostic Technology, Inc.
K843962	CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE	Nov 01, 1984	Substantially Equivalent	R&D Systems, Inc.
K843093	RETIC-CHEX	Oct 23, 1984	Substantially Equivalent	Streck Laboratories, Inc.
K842286	DIA T1, T2 & T3	Sep 11, 1984	Substantially Equivalent	Diatech, Inc.
K842440	SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH	Jul 27, 1984	Substantially Equivalent	Anco Medical Reagents & Assoc.
K842109	TECHNICON TEST POINT ASSAYED HEMATOLOGY	Jul 27, 1984	Substantially Equivalent	Technicon Instruments Corp.
K841531	PARA-TEK	Jul 27, 1984	Substantially Equivalent	Streck Laboratories, Inc.
K842017	PARA 4	Jun 26, 1984	Substantially Equivalent	Streck Laboratories, Inc.
K841239	ASSIGNED VALUE FOR MEAN PLATELET	May 02, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K840302	PLT - 4 PLATELET	Mar 12, 1984	Substantially Equivalent	R&D Systems, Inc.
K834371	TRI-COUNT 10	Mar 09, 1984	Substantially Equivalent	Hematology Marketing Assoc.
K834043	MSI-HC HEMATOLOGY CONTROL	Jan 03, 1984	Substantially Equivalent	Medical Specialties, Inc.
K833563	HC PLUS	Jan 03, 1984	Substantially Equivalent	Coulter Electronics, Inc.
K833130	TRI-COUNT 7	Oct 20, 1983	Substantially Equivalent	Hematology Marketing Assoc.
K831704	TECHNICON H6000 SYSTEM CONTROL	Jul 06, 1983	Substantially Equivalent	Technicon Instruments Corp.
K830864	WHITE BLOOD CELL CONTROL	Jun 15, 1983	Substantially Equivalent	Control Diagnostics
K831094	PARA LASAR	Jun 08, 1983	Substantially Equivalent	Streck Laboratories, Inc.
K820731	HEMATALL-C PLUS HEMATOLOGY CONTROLS	May 12, 1982	Substantially Equivalent	Fisher Scientific Co., LLC
K820401	ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW	Mar 15, 1982	Substantially Equivalent	Orhto Diagnostic Systems, Inc.
K820400	ORTHO* HEMATOLOGY CONTROL 8 NORMAL	Mar 15, 1982	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K812280	HEMATOLOGY CONTROL	Sep 09, 1981	Substantially Equivalent	American Dade
K812237	HEMOTOLOGY QUALITY CONTROL MIXTURE	Sep 09, 1981	Substantially Equivalent	American Dade
K812357	VENTREX DATA REDUCTION & QUAL. CONTR. SY	Sep 01, 1981	Substantially Equivalent	Ventrex Laboratories, Inc.
K810756	HEMOTOLOGY QUALITY CONTROL MIXTURES	Jun 30, 1981	Substantially Equivalent	Scientific Standards, Inc.
K801054	THROMBO-TEST (X)	Mar 13, 1981	Substantially Equivalent	Medtro GmbH
K803084	ORTHO HEMATOLOGY CONTROL ABNORMAL LOW	Dec 31, 1980	Substantially Equivalent	Ortho Instruments
K803083	ORTHO HEMOTOLOGY CONTROL-NORMAL	Dec 31, 1980	Substantially Equivalent	Ortho Instruments
K803073	ORTHO HEMATOLOGY CONTROL	Dec 31, 1980	Substantially Equivalent	Ortho Instruments
K802267	PLT-4 SIZE-CHECK	Nov 12, 1980	Substantially Equivalent	R&D Systems, Inc.
K802265	CBC PLT-4	Nov 12, 1980	Substantially Equivalent	R&D Systems, Inc.
K802143	CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET	Oct 10, 1980	Substantially Equivalent	American Dade
K802142	CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL	Oct 10, 1980	Substantially Equivalent	American Dade
K802141	CH-60 PLUS WHOLE BLOOD PLATELET CONTROL	Oct 10, 1980	Substantially Equivalent	American Dade
K801267	RED BLOOD CELL COUNT & HEMATOCRIT CNTL	Jul 14, 1980	Substantially Equivalent	Bioscientific
K801265	WHITE BLOOD CELL COUNT CONTROL LEVELS	Jul 14, 1980	Substantially Equivalent	Bioscientific
K800938	TRI-CHECK	May 08, 1980	Substantially Equivalent	Scientific Standards, Inc.
K800780	SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS	Apr 24, 1980	Substantially Equivalent	Sandare Chemical Co., Inc.
K800361	HEMATO-CHEX	Apr 04, 1980	Substantially Equivalent	Streck Laboratories, Inc.
K792606	WHOLE BLOOD PLATELET CONTROL NORMAL,	Feb 13, 1980	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K792467	PLATELET-CHEX FOR BLOOD CENTERS	Dec 31, 1979	Substantially Equivalent	Streck Laboratories, Inc.
K792209	SANDARE HEMOGLOBIN CONTROLS	Dec 04, 1979	Substantially Equivalent	Sandare Chemical Co., Inc.
K792055	FISHER DIAGNOSTICS HEMATOLOGY CONTROLS	Nov 05, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K791772	COUNTER-CHECK PLUS NORMAL, HIGH ABN.	Oct 11, 1979	Substantially Equivalent	Diagnostic Technology, Inc.
K791750	COUNTER-CHECK PLUS	Oct 11, 1979	Substantially Equivalent	Diagnostic Technology, Inc.
K791228	PARA-8	Aug 03, 1979	Substantially Equivalent	Streck Laboratories, Inc.
K791227	PARA-7	Aug 03, 1979	Substantially Equivalent	Streck Laboratories, Inc.
K791226	PLATELET-CHEX PLUS	Aug 03, 1979	Substantially Equivalent	Streck Laboratories, Inc.
K791030	HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL	Jun 22, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K790826	COAGULATION ARP	May 31, 1979	Substantially Equivalent	Helena Laboratories
K790457	HEMOGLOBIN CONTROLS	Apr 04, 1979	Substantially Equivalent	Data Medical Associates, Inc.
K790415	HCP-7	Apr 04, 1979	Substantially Equivalent	Bioscientific
K790525	HEMATROL S HEMATOLOGY CONTROLS	Apr 03, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K781969	BLOOD, HEMATOLOGY REFERENCE CONTROL	Jan 03, 1979	Substantially Equivalent	Coulter Electronics, Inc.
K781786	QUANTICEL HHR # L500 AND L501	Nov 15, 1978	Substantially Equivalent	Bhp Diagnostix, Inc.
K781745	QUANTICEL HHR, L531 AND L532	Nov 15, 1978	Substantially Equivalent	Bhp Diagnostix, Inc.
K781573	ABNORMAL HEMATOLOGY CONTROL UNASSAYED	Oct 17, 1978	Substantially Equivalent	Ortho Diagnostics, Inc.
K781572	NORMAL HEMATOLOGY CONTROL UNASSAYED	Oct 17, 1978	Substantially Equivalent	Ortho Diagnostics, Inc.
K781247	QUANTICEL-HRP	Sep 14, 1978	Substantially Equivalent	Bhp Diagnostix, Inc.
K781077	CONTROL, HEMATOLOGY, CH-60	Jul 27, 1978	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K780980	PLATELET CONTROL	Jul 27, 1978	Substantially Equivalent	Bhp Diagnostix, Inc.
K780835	ARANTROL	Jun 22, 1978	Substantially Equivalent	Aranco Diagnostic Laboratories, Inc.
K780714	PLATELET CONTROL	Jun 06, 1978	Substantially Equivalent	Bhp Diagnostix, Inc.
K780140	CELL-CHEX	Mar 27, 1978	Substantially Equivalent	Streck Laboratories, Inc.
K772195	HEMATOLOGY REFERENCE CONTROLS	Feb 03, 1978	Substantially Equivalent	R&D Systems, Inc.
K771753	HEMATOLOGY REFERENCE CONTROL	Nov 28, 1977	Substantially Equivalent	Coulter Electronics, Inc.
K770384	MNITROL HEMOTOL. REF. AND CONTROL	Apr 08, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K770386	LATELET, CONTROL, NORMAL & ABNORMAL	Mar 21, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K770095	PLATELET CONTROL, NORMAL & ABNORMAL	Feb 28, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K770020	PLATELET-CHEX-HUMAN	Feb 16, 1977	Substantially Equivalent	Streck Laboratories, Inc.
K760682	4C ABNORMAL LOW-HIGH (8 X 6 M1)	Oct 08, 1976	Substantially Equivalent	Coulter Electronics, Inc.
K760597	BIOTROL-NORMAL	Oct 08, 1976	Substantially Equivalent	Boehringer Mannheim Corp.
K760596	BIOTROL-ABNORMAL	Oct 08, 1976	Substantially Equivalent	Boehringer Mannheim Corp.
K760549	PLATELET CONTROLS, NORMAL & ABNORMAL	Oct 08, 1976	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K760162	HEMATOLOGY CONTROL	Aug 04, 1976	Substantially Equivalent	Biological Corp. of America