Product Code: GGP FDA class 2 21 CFR 864.7290

Test, Qualitative And Quantitative Factor Deficiency

Hematology

The Test, Qualitative and Quantitative Factor Deficiency (product code GGP) is a hematology assay system used to detect and measure deficiencies in specific coagulation factors, supporting the diagnosis of inherited or acquired bleeding disorders such as hemophilia. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7290 in the Hematology specialty (HE), it is eligible for third-party review.

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510(k)s

190

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: GGP
Device Class: FDA class 2
Regulation Number: 864.7290
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 190 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251440	CRYOcheck Chromogenic Factor VIII	Aug 25, 2025	Substantially Equivalent	Precision Biologic, Inc.
K230852	HemosIL Chromogenic Factor IX	Dec 13, 2023	Substantially Equivalent	Instrumentation Laboratory Company
K220728	vWF Ag	Jun 02, 2023	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K214002	CRYOcheck Chromogenic Factor IX	Dec 23, 2022	Substantially Equivalent	Precision Biologic, Inc.
K223402	HemosIL von Willebrand Factor Antigen	Dec 09, 2022	Substantially Equivalent	Instrumentation Laboratory CO
K200033	HemosIL von Willebrand Factor Antigen	Aug 19, 2020	Substantially Equivalent	Instrumentation Laboratory CO
K193204	Cryocheck Chromogenic Factor VIII	Jul 17, 2020	Substantially Equivalent	Precision Biologic
K183440	CRYOcheck FVIII Inhibitor Kit	Mar 12, 2019	Substantially Equivalent	Precision Biologic, Inc.
K181525	INNOVANCE Free PS Ag	Sep 07, 2018	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K133005	HEMOSIL VON WILLEBRAND ACTIVITY ASSAY	Mar 13, 2014	Substantially Equivalent	Instrumentation Laboratory CO
K102164	HEMOSIL PROTEIN S ACTIVITY ASSAY	Mar 17, 2011	Substantially Equivalent	Instrumentation Laboratory CO
K092170	STA LIATEST FREE PS	Dec 22, 2009	Substantially Equivalent	Diagnostica Stago, Inc.
K082631	THROMBO TEK PSE, MODEL 90-480	Dec 17, 2008	Substantially Equivalent	R2 Diagnostics, Inc.
K082205	FACTOR VIII ANTIBODY SCREEN	Nov 20, 2008	Substantially Equivalent	Genetic Testing Institute
K063323	SPECTROLYSE PAI-1, MODEL 101201	Aug 15, 2007	Substantially Equivalent	American Diagnostica, Inc.
K070635	HEMOSIL PROCLOT	Mar 29, 2007	Substantially Equivalent	Instrumentation Laboratory CO
K062530	TRIAGE PROTEIN C TEST	Jan 29, 2007	Substantially Equivalent	Biosite Incorporated
K062430	HEMOSIL PROTEIN C	Sep 01, 2006	Substantially Equivalent	Instrumentation Laboratory CO
K052825	VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG	Jan 20, 2006	Substantially Equivalent	Affinity Biologicals, Inc.
K053499	HEMOSIL PROS	Jan 13, 2006	Substantially Equivalent	Instrumentation Laboratory CO
K050365	BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202	Dec 27, 2005	Substantially Equivalent	Hyphen Biomed
K050448	CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5	Sep 23, 2005	Substantially Equivalent	Horiba Abx
K051054	VISULIZE FACTOR IX ANTIGEN KIT	Jun 29, 2005	Substantially Equivalent	Affinity Biologicals, Inc.
K043571	CRYOCHECK CLOT S	Mar 18, 2005	Substantially Equivalent	Precision Biologic, Inc.
K042576	COATEST SP FVIII	Dec 02, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K040987	CRYOCHECK CLOT C	Jun 18, 2004	Substantially Equivalent	Precision Biologic, Inc.
K040843	HEMOSIL VON WILLEBRAND ACTIVITY	Apr 30, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K032139	REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826	Apr 05, 2004	Substantially Equivalent	Corgenix, Inc.
K033631	MODIFICATION TO COATEST FACTOR VIII	Dec 15, 2003	Substantially Equivalent	Instrumentation Laboratory CO
K023990	CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50	Mar 19, 2003	Substantially Equivalent	Precision Biologic
K022290	PROTEIN S AC	Aug 27, 2002	Substantially Equivalent	Dade Behring, Inc.
K013492	IMUBIND TPA ELISA, MODEL 860	Mar 13, 2002	Substantially Equivalent	American Diagnostica, Inc.
K013168	IMUBIND PLASMA PAI-1 ELISA,MODEL 822	Mar 07, 2002	Substantially Equivalent	American Diagnostica, Inc.
K012386	ACTICLOT PROTEIN S, MODEL 843L	Sep 14, 2001	Substantially Equivalent	American Diagnostica, Inc.
K011424	IL TEST PROS	Jun 25, 2001	Substantially Equivalent	Instrumentation Laboratory CO
K010963	STA-LIATEST FREE PROTEIN S TEST KIT	Jun 06, 2001	Substantially Equivalent	Diagnostica Stago, Inc.
K010379	IL TEST FREE PROTEIN S	Apr 13, 2001	Substantially Equivalent	Instrumentation Laboratory CO
K002467	COALIZA PROTEIN S-FREE	Oct 13, 2000	Substantially Equivalent	Instrumentation Laboratory CO
K002350	REFACTO LABORATORY STANDARD	Oct 05, 2000	Substantially Equivalent	The Genetics Institute
K002541	PROTEIN C REAGENT	Sep 26, 2000	Substantially Equivalent	Dade Behring, Inc.
K000649	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500	Apr 25, 2000	Substantially Equivalent	Dade Behring, Inc.
K000398	SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200	Apr 17, 2000	Substantially Equivalent	Shield Diagnostics, Ltd.
K993553	GTI-FVIII INHIBITOR ASSAY	Feb 01, 2000	Substantially Equivalent	Genetic Testing Institute
K992704	IL TEST VON WILLEBRAND FACTOR	Nov 01, 1999	Substantially Equivalent	Instrumentation Laboratory CO
K983898	BIOCLOT APC SENSITIVITY	Jan 06, 1999	Substantially Equivalent	Biopool Intl., Inc.
K983914	REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT	Dec 22, 1998	Substantially Equivalent	Corgenix, Inc.
K983107	VFE	Oct 22, 1998	Substantially Equivalent	Ramco Laboratories, Inc.
K981817	COAMATIC PLASMIN INHIBITOR	Sep 28, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K981696	IL TEST PLASMIN INHIBITOR	Aug 27, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K980885	SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY	Aug 21, 1998	Substantially Equivalent	Shield Diagnostics, Ltd.
K981200	IL TEST PLASMINOGEN	May 26, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K974711	COAMATIC PLASMINOGEN	May 01, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K980875	IL TEST PROTEIN C	Apr 21, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K981038	COAMATIC FACTOR VIII	Apr 16, 1998	Substantially Equivalent	Instrumentation Laboratory CO
K971985	N-ASSAY TIA PLASMINOGEN TEST KIT	Oct 20, 1997	Substantially Equivalent	Crestat Diagnostics, Inc.
K972342	REAADS PROTEIN C ANTIGEN TEST KIT	Oct 06, 1997	Substantially Equivalent	Reaads Medical Products, Inc.
K973143	UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA	Sep 25, 1997	Substantially Equivalent	Universal Reagents, Inc.
K971519	ASSERACHROM TPA TEST KIT	Aug 19, 1997	Substantially Equivalent	American Bioproducts Co.
K972482	REAADS PROTEIN S ANTIGEN TEST KIT	Aug 13, 1997	Substantially Equivalent	Reaads Medical Products, Inc.
K972005	REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT	Aug 13, 1997	Substantially Equivalent	Reaads Medical Products, Inc.
K972116	VON WILLEBRAND REAGENT	Jul 25, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K972288	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	Jul 14, 1997	Substantially Equivalent	Universal Reagents, Inc.
K951640	HUMAN PROTEIN S RID TEST KIT	Apr 21, 1997	Substantially Equivalent	The Binding Site, Ltd.
K964459	UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA	Dec 18, 1996	Substantially Equivalent	Universal Reagents, Inc.
K964270	UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA	Dec 18, 1996	Substantially Equivalent	Universal Reagents, Inc.
K962968	PROC APC ASSAY, PROC CONTROL PLASMA	Dec 13, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K963106	CHROMOLIZE PAI-1 KIT	Nov 18, 1996	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K962825	SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY	Nov 15, 1996	Substantially Equivalent	Shield Diagnostics, Ltd.
K961929	FACTOR DEFICIENT PLASMA	Oct 10, 1996	Substantially Equivalent	Universal Reagents, Inc.
K962489	CHROMOLIZE TPA ASSAY KIT	Jul 31, 1996	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K960438	TINTELIZE PAI-1 KIT	Jun 05, 1996	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K955738	BIOCLOT PROTEIN S	Feb 29, 1996	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K952126	AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II	Feb 29, 1996	Substantially Equivalent	Aalto Scientific, Ltd.
K952668	CHROM Z-F:VIII, CAT. NO. 5241	Feb 09, 1996	Substantially Equivalent	Helena Laboratories
K952666	CHROM Z-PROTEIN C, CAT. NO. 5243	Jan 30, 1996	Substantially Equivalent	Helena Laboratories
K952669	CHROM Z-PLASMINOGEN, CAT. NO. 5244	Dec 07, 1995	Substantially Equivalent	Helena Laboratories
K954040	ASSERACHROM TOTAL PROTEIN S KIT	Nov 13, 1995	Substantially Equivalent	American Bioproducts Co.
K954017	ASSERACHROM FREE PROTEIN S KIT	Nov 13, 1995	Substantially Equivalent	American Bioproducts Co.
K943225	COAMATIC FACTOR VIII	Nov 06, 1995	Substantially Equivalent	Pharmacia Hepar, Inc.
K941752	SPECTROLYSE ANTIPLASMIN KIT	Sep 25, 1995	Unknown	Biopool AB
K942087	BIOPOOL VWF ELD KIT AND VWF ELD BULK PLATES	Jul 13, 1995	Substantially Equivalent	Biopool AB
K950015	HUMAN PROTEIN C RID TEST KIT	Mar 06, 1995	Substantially Equivalent	Jay H. Geller
K924425	PROTEIN C REAGENT, COAGULOMETRIC	Jan 24, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K945414	RISTOCETIN COFACTOR ASSAY KIT	Jan 11, 1995	Substantially Equivalent	Chrono-Log Corp.
K934210	HEMOLAB PROTEIN C CHROMOGENIC ASSAY	Dec 22, 1994	Substantially Equivalent	Biomerieux Vitek, Inc.
K934314	TINTELIZER(R) TPA	Feb 23, 1994	Substantially Equivalent	Biopool AB
K925617	MDA PROTEIN ASSAY	Jan 27, 1994	Substantially Equivalent	Organon Teknika Corp.
K934584	SPECTROLYSE FACTOR VII:C	Dec 06, 1993	Substantially Equivalent	Meditech, Inc.
K931906	NEW STACHROM PROTEIN C TEST KIT	Nov 05, 1993	Substantially Equivalent	American Bioproducts Co.
K930235	HEMOCHRON/FACTOR VI WHOLE BLOOD FACTOR VIII ASSAY	Sep 02, 1993	Substantially Equivalent	Technidyne Corp.
K930327	IL TEST(TM) PROTEIN S	Apr 12, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K924884	IL TEST(TM) PRO-CHROM	Jan 14, 1993	Substantially Equivalent	Instrumentation Laboratory CO
K922201	COAMATE PROTEIN C CHROMOGENIC ASSAY	Dec 07, 1992	Substantially Equivalent	Chromogenix AB
K922782	SPECTROLYSE/PL PAI KIT	Oct 09, 1992	Substantially Equivalent	Biopool AB
K921449	NEW STACHROM ANTIPLASMIN	Sep 23, 1992	Substantially Equivalent	American Bioproducts Co.
K920012	IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM	Aug 12, 1992	Substantially Equivalent	Instrumentation Laboratory CO
K920981	RISTOCETIN COFACTOR ASSAY/VON WILLEBRAND FACT ASSA	Apr 17, 1992	Substantially Equivalent	Medical Diagnostic Technologies, Inc.
K914818	DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY	Jan 15, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K915163	PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES	Jan 06, 1992	Substantially Equivalent	Biopool AB
K914307	SPECTROLYSE PROTEIN C KIT	Dec 09, 1991	Substantially Equivalent	Biopool AB
K912711	IL TEST PROCLOT ASSAY STYSTEM	Oct 09, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K913424	STACLOT(R) PROTEIN S TEST KIT	Oct 08, 1991	Substantially Equivalent	American Bioproducts Co.
K912468	LIATEST PROTEIN S KIT	Oct 02, 1991	Substantially Equivalent	American Bioproducts Co.
K912025	SPECTROLYSE PLASMINOGEN SK KIT	Aug 22, 1991	Substantially Equivalent	Biopool AB
K903468	DADE PROTEIN C CLOTTING ASSAY	Feb 26, 1991	Substantially Equivalent	Baxter Healthcare Corp
K904247	FREE PROTEIN S REAGENT CAT. NO. 5363	Jan 18, 1991	Substantially Equivalent	Helena Laboratories
K902566	BIOPOOL PROTEIN C EID KIT AND BULK PLATES	Aug 09, 1990	Substantially Equivalent	Biopool AB
K902528	BIOCLOT C KIT	Aug 09, 1990	Substantially Equivalent	Biopool AB
K900399	ORTHOKROME* PLASMINOGEN	Mar 15, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K900398	ORTHOKROME* PROTEIN C	Mar 15, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K900397	ORTHOKROME* ANTIPLASMIN	Mar 15, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K900395	ORTHOKROME* FACTOR VIII	Mar 15, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K896174	PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359	Mar 15, 1990	Substantially Equivalent	Helena Laboratories
K897136	PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357	Feb 05, 1990	Substantially Equivalent	Helena Laboratories
K892859	THE STAGO VIII DEFICIENT PLASMA KIT	Jun 23, 1989	Substantially Equivalent	American Bioproducts Co.
K890634	BERICHROM PROTEIN C KIT	Apr 21, 1989	Substantially Equivalent	Behring Diagnostics, Inc.
K884797	BERICHROM ALPHA-2-ANTIPLASMIN	Apr 21, 1989	Substantially Equivalent	Behring Diagnostics, Inc.
K884941	ACTICLOT C KIT	Mar 13, 1989	Substantially Equivalent	American Diagnostic Corp.
K884940	RELLPLATE C KIT, RELLPLATE C BULK PLATES	Mar 13, 1989	Substantially Equivalent	American Diagnostic Corp.
K890409	DADE(R) PLASMINOGEN CHROMOGENIC ASSAY	Feb 27, 1989	Substantially Equivalent	Baxter Healthcare Corp
K884881	DADE PROTEIN C CHROMOGENIC ASSAY	Feb 02, 1989	Substantially Equivalent	Baxter Healthcare Corp
K884551	DADE FACTOR IX CHROMOGENIC ASSAY	Dec 30, 1988	Substantially Equivalent	Baxter Healthcare Corp
K884544	DADE FACTOR VIII CHROMOGENIC ASSAY	Dec 30, 1988	Substantially Equivalent	Baxter Healthcare Corp
K884058	COATEST PROTEIN C	Dec 13, 1988	Substantially Equivalent	Kabivitrum, Inc.
K882603	STACHROM ANTIPLASMIN CONTROL	Sep 02, 1988	Substantially Equivalent	American Bioproducts Co.
K882602	STACHROM ANTIPLASMIN TEST KIT	Sep 02, 1988	Substantially Equivalent	American Bioproducts Co.
K881037	SPECTROLYSE/FIBRIN	Jul 01, 1988	Substantially Equivalent	Cytrx Biopool, Ltd.
K874940	CALIBRATION REFERENCE PLASMA	Feb 09, 1988	Substantially Equivalent	Baxter Healthcare Corp
K874097	STACHROM VIII:C TEST KIT	Dec 03, 1987	Substantially Equivalent	American Bioproducts Co.
K872941	SPECTRO C	Sep 04, 1987	Substantially Equivalent	Ramco Laboratories, Inc.
K872479	ASSERACHROM PROTEIN S TEST KIT	Aug 21, 1987	Substantially Equivalent	American Bioproducts Co.
K871039	STACHROM PROTEIN C TEST KIT	May 21, 1987	Substantially Equivalent	American Bioproducts Co.
K870917	PROTEIN S CONTROL PLASMA	Apr 23, 1987	Substantially Equivalent	American Bioproducts Co.
K864701	VWF IMMUNOBLOT	Mar 30, 1987	Substantially Equivalent	Ramco Laboratories, Inc.
K870354	IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN)	Feb 10, 1987	Substantially Equivalent	American Dade
K870353	IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN)	Feb 10, 1987	Substantially Equivalent	American Dade
K864480	IL TEST 84668-15, FACTOR VIII CONTROL PLASMA	Jan 21, 1987	Substantially Equivalent	Instrumentation Laboratory CO
K864497	COAGULATION EXTRINSIC DEFICIENT PLASMAS	Jan 05, 1987	Substantially Equivalent	Instrumentation Laboratory CO
K864481	COAGULATION INTRINSIC DEFICIENT PLASMAS	Jan 05, 1987	Substantially Equivalent	Instrumentation Laboratory CO
K861475	ASSERA-PLATE PROTEIN C KIT	Jun 25, 1986	Substantially Equivalent	American Bioproducts Co.
K861417	ASSERA-PLATE VWF KIT	Jun 25, 1986	Substantially Equivalent	American Bioproducts Co.
K861079	STACLOT PROTEIN C TEST KIT	Jun 19, 1986	Substantially Equivalent	American Bioproducts Co.
K861049	HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA	May 29, 1986	Substantially Equivalent	Sigma Chemical Co.
K861048	PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765	May 29, 1986	Substantially Equivalent	Sigma Chemical Co.
K861217	VWF-IX:AG CONTROL PLASMA	May 20, 1986	Substantially Equivalent	American Bioproducts Co.
K861216	PROTEIN C CONTROL PLASMA	May 16, 1986	Substantially Equivalent	American Bioproducts Co.
K861159	SPECTRO VWF	May 01, 1986	Substantially Equivalent	Ramco Laboratories, Inc.
K860371	ASSERACHROM VWF KIT	Apr 04, 1986	Substantially Equivalent	American Bioproducts Co.
K854312	ASSERACHROM IX:AG	Feb 04, 1986	Substantially Equivalent	American Bioproducts Co.
K854014	ASSERA PLATE IX:AG KIT	Jan 03, 1986	Substantially Equivalent	American Bioproducts Co.
K853462	COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA	Aug 29, 1985	Substantially Equivalent	American Dade
K853461	COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA	Aug 29, 1985	Substantially Equivalent	American Dade
K843451	FACTOR XII DEFICIENT PLASMA B12D	Nov 19, 1984	Substantially Equivalent	Sigma Chemical Co.
K843438	FACTOR XI DEFICIENT PLASMA B11D	Nov 19, 1984	Substantially Equivalent	Sigma Chemical Co.
K843310	FACTOR X DEFICIENT PLASMA, BLOD HUMAN	Nov 19, 1984	Substantially Equivalent	Sigma Chemical Co.
K843215	FACTOR IX DEFICIENT PLASMA, B9D -	Nov 19, 1984	Substantially Equivalent	Sigma Chemical Co.
K842617	VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT	Oct 01, 1984	Substantially Equivalent	American Dade
K841957	BOVINE FACTOR XA-HUMAN FACTOR XA	Jul 19, 1984	Substantially Equivalent	Haemachem, Inc.
K841708	MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII	Jul 19, 1984	Substantially Equivalent	Meloy Laboratories, Inc.
K841461	COAGULATION CONTROL PLASMA LEVEL 1/2/3	May 02, 1984	Substantially Equivalent	Diatech, Inc.
K840928	FACTOR DEFICIENT SUBSTRATE PLASMA VIII	Apr 30, 1984	Substantially Equivalent	Diatech, Inc.
K840927	FACTOR DEFICIENT SUBSTRATE PLASMA II	Apr 30, 1984	Substantially Equivalent	Diatech, Inc.
K841364	COAGULATION FACTOR V DEFICIENT SUBSTR	Apr 25, 1984	Substantially Equivalent	American Dade
K840329	RISTOCETIN COFACTOR ASSAY	Apr 05, 1984	Substantially Equivalent	Helena Laboratories
K840114	COAGULATION FACTOR DEFICIENT PLASMA	Feb 04, 1984	Substantially Equivalent	Medical Specialties Laboratories
K834051	PROTOPATH FACTOR VIII ASSAY	Feb 04, 1984	Substantially Equivalent	American Dade
K834050	PROTOPATH FACTOR IX ASSAY	Feb 04, 1984	Substantially Equivalent	American Dade
K833892	COATEST FACTOR VIII	Jan 30, 1984	Substantially Equivalent	Kabivitrum, Inc.
K834031	FACTOR II DEFICIENT SUBSTRATE PLASMA	Dec 16, 1983	Substantially Equivalent	Helena Laboratories
K832372	DIACROM * FACTOR X KIT HA31	Sep 29, 1983	Substantially Equivalent	Wellcome Diagnostics
K832114	COATEST FACTOR X	Aug 26, 1983	Substantially Equivalent	Kabivitrum, Inc.
K823453	VON WILLEBRAND FACTOR ASSAY	Jan 21, 1983	Substantially Equivalent	General Diagnostics
K823267	FACTOR VIII RELATED ANTIGEN ROCKET EID	Dec 28, 1982	Substantially Equivalent	Helena Laboratories
K821963	EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.	Jul 27, 1982	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K820085	DADE FACTOR ASSAY REFERENCE PLASMA	Feb 23, 1982	Substantially Equivalent	American Dade
K812975	LANCER COAGENT HUMAN VACTOR VIII PLASMA	Nov 16, 1981	Substantially Equivalent	Sherwood Medical Co.
K812974	LANCER COAGENT HUMAN FACTOR 1X PLASMA	Nov 16, 1981	Substantially Equivalent	Sherwood Medical Co.
K812431	FACTOR VIII DEFICIENT PLASMA #B8D	Sep 23, 1981	Substantially Equivalent	Sigma Chemical Co.
K802356	VON WILLEBRAND FACTOR ASSAY	Dec 01, 1980	Substantially Equivalent	Bio/Data Corp.
K792656	HELENA FACTOR XII DEFICIENT	Jan 24, 1980	Substantially Equivalent	Helena Laboratories
K792511	HELENA FACTOR VII DEFICIENT SUB. PLASMA	Dec 31, 1979	Substantially Equivalent	Helena Laboratories
K792508	HELENA FACTOR X DEFICIENT SUBSTRATE	Dec 31, 1979	Substantially Equivalent	Helena Laboratories
K792507	HELENA FACTOR V DEFICIENT SUBSTRATE	Dec 31, 1979	Substantially Equivalent	Helena Laboratories
K792476	HELENA FACTOR XI DEFICIENT SUBSTRATE	Dec 31, 1979	Substantially Equivalent	Helena Laboratories
K792475	HELENA FACTOR IX DEFICIENT SUBSTRATE	Dec 31, 1979	Substantially Equivalent	Helena Laboratories
K792336	HELENA FACTOR II DEFICIENT SUB. PLASMA	Dec 27, 1979	Substantially Equivalent	Helena Laboratories
K792335	HELENA FACTOR VIII DEFICIENT SUB. PLASMA	Dec 04, 1979	Substantially Equivalent	Helena Laboratories
K791794	FACTOR VII DEFICIENT PLASMA	Oct 01, 1979	Substantially Equivalent	Sigma Chemical Co.
K790423	FACTOR V DEFICIENT	Apr 04, 1979	Substantially Equivalent	Sigma Chemical Co.
K761058	QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT	Feb 07, 1977	Substantially Equivalent	Bio/Data Corp.