Product Code: JPA FDA class 2 21 CFR 864.5425

System, Multipurpose For In Vitro Coagulation Studies

Hematology

The System, Multipurpose for In Vitro Coagulation Studies is a hematology laboratory instrument capable of performing multiple coagulation tests on patient plasma specimens, supporting the evaluation of coagulation factor deficiencies, monitoring anticoagulant therapy, and diagnosing bleeding or thrombotic disorders. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification before marketing. It carries product code JPA and is regulated under 21 CFR 864.5425, within the Hematology medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

181

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JPA
Device Class: FDA class 2
Regulation Number: 864.5425
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 181 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253658	STA Satellite Max®	Apr 27, 2026	Substantially Equivalent	Diagnostica Stago, Inc.
K250965	Automated Blood Coagulation Analyzer CN-Series (CN-6000)	Jun 02, 2025	Substantially Equivalent	Sysmex America, Inc.
K251024	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	Apr 30, 2025	Substantially Equivalent	Haemonetics
K243858	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge	Jan 15, 2025	Substantially Equivalent	Haemonetics Corporation
K232018	Citrated: K, KH, RTH, FFH	Mar 29, 2024	Substantially Equivalent	Haemonetics Corporation
K233790	ACL TOP 970 CL	Dec 29, 2023	Substantially Equivalent	Instrumentation Laboratory
K221359	ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM	Sep 29, 2023	Substantially Equivalent	Instrumentation Laboratory CO
K212183	STA R Max 3, STA Compact Max 3	Jun 07, 2023	Substantially Equivalent	Diagnostica Stago S.A.S
K201440	ROTEM sigma Thromboelastometry System	Jul 08, 2022	Substantially Equivalent	Tem Innovations GmbH
K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2	Dec 29, 2021	Substantially Equivalent	Accriva Diagnostics, Inc.
K193041	Hemochron Signature Elite	Nov 22, 2019	Substantially Equivalent	Accriva Diagnostics, Inc.
K183390	QNext and DG-PT	Aug 21, 2019	Substantially Equivalent	Diagnostic Grifols, S.A.
K183160	TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge	May 09, 2019	Substantially Equivalent	Haemonetics Corporation
K173202	CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set	May 09, 2018	Substantially Equivalent	Sekisui Medical Co., Ltd.
K172286	Automated Blood Coagulation Analyzer CS-2500	Dec 18, 2017	Substantially Equivalent	Siemens Healthcare Diagnostic Products GmbH
K172333	Sysmex CS-5100	Oct 31, 2017	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K160502	TEG 6s Hemostasis System	Apr 19, 2017	Substantially Equivalent	Haemonetics Corporation
K170314	ACL AcuStar	Mar 03, 2017	Substantially Equivalent	Instrumentation Laboratory CO
K162688	Sysmex CS-2100i	Dec 26, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K162420	Sysmex Automated Blood Coagulation Analyzer CS-5100	Dec 12, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K161317	Sysmex Automated Blood Coagulation Analyzer CS-5100	Sep 02, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K161312	Sysmex Automated Blood Coagulation Analyzer CS-2100i	Sep 01, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K151259	Sysmex Automated Blood Coagulation Analyzer CS-2100i	Jan 26, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics Products GmbH
K150678	Sysmex Automated Blood Coagulation Analyzer CS-5100	Jan 11, 2016	Substantially Equivalent	Siemens Healthcare Diagnostic Products GmbH
K151867	STA R MAX	Aug 07, 2015	Substantially Equivalent	Diagnostica Stago S.A.S
K150041	CORA (Coagulation Resonance Analysis) System	Jun 26, 2015	Substantially Equivalent	Coramed Technologies, LLC
K130090	STA COMPACT MAX	Feb 12, 2013	Substantially Equivalent	Diagnostica Stago, Incorporated
K101533	EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM	Aug 10, 2011	Substantially Equivalent	Tem Innovations GmbH
K083842	ROTEM DELTA THROMBOELASTOMETRY SYSTEM	Mar 23, 2010	Substantially Equivalent	Pentapharm GmbH
K093167	STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER	Dec 22, 2009	Substantially Equivalent	Diagnostica Stago, Inc.
K093001	STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER	Dec 18, 2009	Substantially Equivalent	Diagnostica Stago, Incorporated
K083896	DESTINY MAX COAGULATION ANALYZER	Jul 02, 2009	Substantially Equivalent	Trinity Biotech
K083518	ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS	Mar 13, 2009	Substantially Equivalent	Instrumentation Laboratory CO
K083175	BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2	Jan 26, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K083159	BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2	Jan 26, 2009	Substantially Equivalent	Siemens Healthcare Diagnostics
K082248	STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER	Dec 12, 2008	Substantially Equivalent	Diagnostica Stago, Inc.
K082675	STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER	Oct 10, 2008	Substantially Equivalent	Diagnostica Stago, Inc.
K071265	SMARTCHECK INR SYSTEM	Nov 30, 2007	Substantially Equivalent	Inverness Medical Innovations, Inc.
K061014	ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP	May 10, 2006	Substantially Equivalent	Helena Laboratories
K060162	ACL ELITE; ACL ELITE PRO	Feb 21, 2006	Substantially Equivalent	Instrumentation Laboratory CO
K051030	COAG-A-MATE MTX III	Dec 23, 2005	Substantially Equivalent	bioMerieux, Inc.
K050053	HEMORAM/AGGRAM ANALYZER	Jul 11, 2005	Substantially Equivalent	Helena Laboratories
K050243	IMMEDIA PROTHROMBIN TIME SYSTEM	Jun 06, 2005	Substantially Equivalent	Farallon Medial, Inc.
K050513	MDA B.30	Apr 01, 2005	Substantially Equivalent	bioMerieux, Inc.
K050016	HEMOCHRON SIGNATURE ELITE	Feb 10, 2005	Substantially Equivalent	International Technidyne Corp.
K040359	HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2	Mar 19, 2004	Substantially Equivalent	Instrumentation Laboratory CO
K033137	POTENS +	Dec 08, 2003	Substantially Equivalent	Wada, Inc.
K030818	HEMOCHRON RESPONSE/SYSTEM	Apr 02, 2003	Substantially Equivalent	International Technidyne Corp.
K023141	MODIFICATION TO STANDARD HUMAN PLASMA	Jan 16, 2003	Substantially Equivalent	Dade Behring, Inc.
K021162	AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED	Aug 30, 2002	Substantially Equivalent	Sigma Diagnostics, Inc.
K020798	HEMOCHRON JR. SIGNATURE +	Mar 28, 2002	Substantially Equivalent	International Technidyne Corp.
K013114	BCS SYSTEM	Nov 09, 2001	Substantially Equivalent	Dade Behring, Inc.
K011665	BCT SYSTEM	Aug 09, 2001	Substantially Equivalent	Dade Behring, Inc.
K011235	SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500	Jul 20, 2001	Substantially Equivalent	Dade Behring, Inc.
K010494	SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500	May 01, 2001	Substantially Equivalent	Dade Behring, Inc.
K002080	BEHRING COAGULATION SYSTEM, MODEL BCS	Nov 16, 2000	Substantially Equivalent	Dade Behring, Inc.
K002177	THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES	Sep 14, 2000	Substantially Equivalent	Haemoscope Corp.
K994349	COAGUCHEK S SYSTEM, MODEL 2138280	Sep 06, 2000	Substantially Equivalent	Roche Diagnostics Corp.
K002400	MODIFICATION OF ACL ADVANCE	Aug 30, 2000	Substantially Equivalent	Instrumentation Laboratory CO
K001064	BEHRING COAGULATION TIMER ANALYZER (BCT)	Jun 21, 2000	Substantially Equivalent	Dade Behring, Inc.
K001067	DADE BEHRING COAGULATION ANALYZER (BCT)	Jun 20, 2000	Substantially Equivalent	Dade Behring, Inc.
K000973	BEHRING COAGULATION SYSTEM (BCS)	May 26, 2000	Substantially Equivalent	Dade Behring, Inc.
K993678	THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES	May 05, 2000	Substantially Equivalent	Haemoscope Corp.
K000053	ACL 9000 SYSTEM	Mar 15, 2000	Substantially Equivalent	Instrumentation Laboratory CO
K992959	BEHRING COAGULATION SYSTEM (BCS)	Jan 11, 2000	Substantially Equivalent	Dade Behring, Inc.
K984501	DADE BEHRING BFTII	Jul 28, 1999	Substantially Equivalent	Dade Behring, Inc.
K990566	TAS ANALYZER, MODEL 1009	May 14, 1999	Substantially Equivalent	Cardiovascular Diagnostics, Inc.
K990449	HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE	Apr 13, 1999	Substantially Equivalent	International Technidyne Corp.
K983892	COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P	Apr 13, 1999	Substantially Equivalent	Roche Diagnostics/Boehringer Mannheim GmbH
K983460	STAR AUTOMATED MULTI-PARAMETRIC ANALYZER	Nov 12, 1998	Substantially Equivalent	American Bioproducts Co.
K981711	SYSMEX AUTOMATED COAGULATION ANALYZER CA-500	Sep 30, 1998	Substantially Equivalent	Dade Behring, Inc.
K980839	AVOCET PT	Sep 30, 1998	Substantially Equivalent	Avocet Medical, Inc.
K981815	HEPTRAC ELECTRONIC QUALITY CONTROL	Jul 30, 1998	Substantially Equivalent	Medtronic Blood Management
K974799	HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE	Jul 07, 1998	Substantially Equivalent	International Technidyne Corp.
K974569	COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING	Jan 09, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K972260	CS-400 COAGULATION ANALYZER SYSTEM (A1208)	Oct 20, 1997	Substantially Equivalent	Sigma Diagnostics, Inc.
K970431	BEHRING COAGULATION SYSTEM	May 05, 1997	Substantially Equivalent	Behring Diagnostics, Inc.
K964946	SYSMEX CA-1000/SYSMEX CA-5000	Mar 18, 1997	Substantially Equivalent	Sysmex Corp.
K961908	THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451	Dec 10, 1996	Substantially Equivalent	Helena Laboratories
K960875	KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632)	Sep 10, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K954202	PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS	Jun 20, 1996	Substantially Equivalent	Medtronic Hemotec, Inc.
K955720	AMAX CS-190 COAGULATION ANALYZER SYSTEM	Mar 13, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K955724	KC 1A COAGULATION ANALYZER/SET	Mar 12, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K955735	KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM	Mar 11, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K952625	COAGUCHEK SYSTEM	Nov 21, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K951891	ACL FUTURA COAGULATION SYSTEM	Nov 03, 1995	Substantially Equivalent	Instrumentation Laboratory CO
K952560	SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER	Sep 05, 1995	Substantially Equivalent	Sienco, Inc.
K951497	CASCASE 480 SNSLYZER	Sep 01, 1995	Substantially Equivalent	Helena Laboratories
K926551	BEHRING FIBRINTIMER A	Apr 18, 1995	Substantially Equivalent	Behring Diagnostics, Inc.
K942097	TOA MEDICAL ELECTRONICS CA-5000	Mar 24, 1995	Substantially Equivalent	Sysmex Corp.
K942096	TOA MEDICAL ELECTRONICS CA-1000	Mar 24, 1995	Substantially Equivalent	Sysmex Corp.
K940957	HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM	Oct 18, 1994	Substantially Equivalent	International Technidyne Corp.
K940840	ACT CONTROL SET	Jul 19, 1994	Substantially Equivalent	Sigma Diagnostics, Inc.
K940401	JR. MICROCOAGULATION SYSTEM	May 11, 1994	Substantially Equivalent	International Technidyne Corp.
K933886	TOA MEDICAL ELECTRONICS CA-5000	Jan 27, 1994	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K934747	R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470	Dec 03, 1993	Substantially Equivalent	R & D Batteries, Inc.
K931149	CA-1000 AUTOMATED COAGULATION ANALYZER	Nov 03, 1993	Substantially Equivalent	Toa Medical Electronics USA, Inc.
K933188	DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI	Sep 22, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K930068	HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION	Sep 02, 1993	Substantially Equivalent	Technidyne Corp.
K930454	BOEHRINGER MANNHEIM COAGUCHEK SYSTEM	Aug 05, 1993	Substantially Equivalent	Boehringer Mannheim Corp.
K930849	VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA	Apr 20, 1993	Substantially Equivalent	Organon Teknika Corp.
K925340	COAGULATION CONTROL CONTAINING HEMOGLOBIN	Mar 23, 1993	Substantially Equivalent	Analytical Control Systems, Inc.
K926222	OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376	Feb 12, 1993	Substantially Equivalent	Helena Laboratories
K923761	ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM	Jan 21, 1993	Substantially Equivalent	International Technidyne Corp.
K924509	CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION	Dec 21, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K924453	MULTI-CHANNEL DISCRETE ANALYZER (MDA-180)	Dec 18, 1992	Substantially Equivalent	Organon Teknika Corp.
K924124	BEHRING FIBRINTIMER A	Dec 01, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K924393	STANDARD HUMAN PLASMA	Nov 16, 1992	Substantially Equivalent	Behring Diagnostics, Inc.
K914188	KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM	Aug 26, 1992	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K912087	ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS	Sep 19, 1991	Substantially Equivalent	Instrumentation Laboratory CO
K912061	HEPARIN ADSORBENT	Jul 24, 1991	Substantially Equivalent	Sigma Diagnostics, Inc.
K902458	ACS 0.02 M CALCIUM CHLORIDE	Aug 01, 1990	Substantially Equivalent	Analytical Control Systems, Inc.
K900917	COAG-A-MATE - RA4	Apr 16, 1990	Substantially Equivalent	Organon Teknika Corp.
K900506	MODIFIED COATRON II AND COATRON JR.	Mar 12, 1990	Substantially Equivalent	Astral Medical Systems
K900377	COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN	Mar 06, 1990	Substantially Equivalent	Baxter Healthcare Corp
K894466	HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS	Sep 05, 1989	Substantially Equivalent	Hemotec, Inc.
K894359	CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS	Sep 05, 1989	Substantially Equivalent	Hemotec, Inc.
K893650	PLATELET AGGREGATION PROFILER MODEL PAP-4C	Jun 23, 1989	Substantially Equivalent	Bio/Data Corp.
K884534	PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER	Jan 24, 1989	Substantially Equivalent	Pall Biomedical Products Co.
K885076	COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE	Dec 30, 1988	Substantially Equivalent	Organon Teknika Corp.
K883689	ORTHO OWREN'S BUFFER	Nov 01, 1988	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K883640	KD ONE-STAGE PROTHROMBIN TIME TEST	Oct 31, 1988	Substantially Equivalent	King Diagnostics, Inc.
K883637	KD 0.02 M CALCIUM CHLORIDE SOLUTION	Oct 31, 1988	Substantially Equivalent	King Diagnostics, Inc.
K883635	KD 0.1 M SODIUM CITRATE SOLUTION	Oct 31, 1988	Substantially Equivalent	King Diagnostics, Inc.
K883484	OWREN'S VERONAL BUFFER	Aug 25, 1988	Substantially Equivalent	Helena Laboratories
K882444	COAG-I ANALYZER, ALPHA MODEL	Aug 25, 1988	Substantially Equivalent	Cardiovascular Diagnostic Services
K881367	ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS	Jun 27, 1988	Substantially Equivalent	Instrumentation Laboratory CO
K880713	CLP 0.1 M SODIUM CITRATE SOLUTION	Mar 18, 1988	Substantially Equivalent	Creative Laboratory Products, Inc.
K875089	HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN	Mar 09, 1988	Substantially Equivalent	Hemotec, Inc.
K872377	CHROM-TROL	Jul 09, 1987	Substantially Equivalent	Helena Laboratories
K870831	PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA	Jun 01, 1987	Substantially Equivalent	International Technidyne Corp.
K870771	PT HEPARIN ADSORBENT	Apr 23, 1987	Substantially Equivalent	Probe-Tek, Inc.
K870687	COAGULATION CONTROL, LEVEL III	Apr 20, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K870686	COAGULATION CONTROL, LEVEL II	Apr 20, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K870685	COAGULATION CONTROL, LEVEL I	Apr 20, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K870688	O.O2 M CALCIUM CHLORIDE SOLUTION	Mar 31, 1987	Substantially Equivalent	U. S. Diagnostics, Inc.
K870960	COAG-A-MATE(R) XC	Mar 17, 1987	Substantially Equivalent	Organon Teknika Corp.
K864534	ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER	Feb 06, 1987	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K864532	ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER	Feb 06, 1987	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K864271	IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA	Nov 25, 1986	Substantially Equivalent	Instrumentation Laboratory CO
K862537	KOAGULAB* M COAGULATION SYSTEM	Jul 21, 1986	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K860719	BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)	May 23, 1986	Substantially Equivalent	Biotrack, Inc.
K854938	COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.	Mar 12, 1986	Substantially Equivalent	Diatech, Inc.
K860342	MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP	Mar 04, 1986	Substantially Equivalent	Bio/Data Corp.
K854546	MICROSAMPLE COAGULATION ANALYSER MODEL 110P	Jan 07, 1986	Substantially Equivalent	Bio/Data Corp.
K854090	DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT	Jan 06, 1986	Substantially Equivalent	Diatech, Inc.
K854089	DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT	Jan 06, 1986	Substantially Equivalent	Diatech, Inc.
K854376	HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS	Dec 04, 1985	Substantially Equivalent	Hemotec, Inc.
K853986	THROMBOPLASTIN-R REAGENT	Nov 12, 1985	Substantially Equivalent	American Dade
K853328	KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS	Nov 05, 1985	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K851153	COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE	Nov 05, 1985	Substantially Equivalent	Astral Medical Systems
K853789	ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR	Oct 04, 1985	Substantially Equivalent	Hemotec, Inc.
K853198	ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES	Oct 04, 1985	Substantially Equivalent	Medical Device Consultants, Inc.
K852450	LODE COAGULOMETER MODEL LC-6	Sep 30, 1985	Substantially Equivalent	Lode Corp.
K853246	CALCIUM CHLORIDE	Aug 13, 1985	Substantially Equivalent	Bio/Data Corp.
K853078	CITREX III	Aug 12, 1985	Substantially Equivalent	Bio/Data Corp.
K853077	CITREX II	Aug 12, 1985	Substantially Equivalent	Bio/Data Corp.
K853076	CITREX I	Aug 12, 1985	Substantially Equivalent	Bio/Data Corp.
K851127	DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO	May 29, 1985	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K850409	GEN. DIAG. CHROMOSTRATE REF. PLASMA	May 08, 1985	Substantially Equivalent	Warner-Lambert Co.
K842717	COBAS-FIBRO	Oct 17, 1984	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K841523	OWREN'S VERONAL BUFFERR	Jun 01, 1984	Substantially Equivalent	Diatech, Inc.
K841462	HEPARIN COAGULATION CONTROL PLASMA 1-	Jun 01, 1984	Substantially Equivalent	Diatech, Inc.
K833272	THROMBOPLASTIN - FS	Nov 03, 1983	Substantially Equivalent	American Dade
K832225	ORTHO ABNORMAL COAGULATION LEVEL I/II	Aug 12, 1983	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K812121	DIGICLOT 2-#820	Nov 16, 1981	Substantially Equivalent	Volu Sol Medical Industries
K812122	MULTI CLOT-#819	Nov 10, 1981	Substantially Equivalent	Volu Sol Medical Industries
K812124	MLA ELECTRA 700	Oct 02, 1981	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K792310	NORM-TROL	Dec 04, 1979	Substantially Equivalent	Helena Laboratories
K791586	ELVI 818 DIGICLOT MULTISCAN	Sep 17, 1979	Substantially Equivalent	Volu Sol Medical Industries
K790323	COAG-A-MATE 2001	Mar 21, 1979	Substantially Equivalent	General Diagnostics
K790204	PLASMA, STANDARDIZED NORMAL	Mar 12, 1979	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.
K780810	MLA ELECTRA 750 COAGULATION TIMER	Jun 14, 1978	Substantially Equivalent	Medical Laboratory Automation Systems, Inc.
K770606	ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH	May 06, 1977	Substantially Equivalent	Damon Corp.
K761091	TPC-LYOPHILIZED POOLED HUMAN PLASMA	Feb 01, 1977	Substantially Equivalent	Bio/Data Corp.
K761176	CALCIUM CHLORIDE (0.025M)	Jan 10, 1977	Substantially Equivalent	Bio/Data Corp.
K761175	IMIDAZOLE BUFFER (0.05M)	Jan 10, 1977	Substantially Equivalent	Bio/Data Corp.
K761173	TRIS BUFFERED	Jan 10, 1977	Substantially Equivalent	Bio/Data Corp.
K761172	TRIS BUFFERED SALINE	Jan 10, 1977	Substantially Equivalent	Bio/Data Corp.
K761171	VERONAL BUFFER	Jan 10, 1977	Substantially Equivalent	Bio/Data Corp.
K760594	AUTO-FI COAGULATION INSTRUMENT	Nov 24, 1976	Substantially Equivalent	Dade, Baxter Travenol Diagnostics, Inc.