FDA 510(k) Applications for Medical Device Product Code "JPA"
(System, Multipurpose For In Vitro Coagulation Studies)

FDA 510(k) Number Applicant Device Name Decision Date
K983460 AMERICAN BIOPRODUCTS CO. STAR AUTOMATED MULTI-PARAMETRIC ANALYZER 11/12/1998
K833272 AMERICAN DADE THROMBOPLASTIN - FS 11/03/1983
K853986 AMERICAN DADE THROMBOPLASTIN-R REAGENT 11/12/1985
K902458 ANALYTICAL CONTROL SYSTEMS, INC. ACS 0.02 M CALCIUM CHLORIDE 08/01/1990
K925340 ANALYTICAL CONTROL SYSTEMS, INC. COAGULATION CONTROL CONTAINING HEMOGLOBIN 03/23/1993
K851153 ASTRAL MEDICAL SYSTEMS COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGE 11/05/1985
K900506 ASTRAL MEDICAL SYSTEMS MODIFIED COATRON II AND COATRON JR. 03/12/1990
K980839 AVOCET MEDICAL, INC. AVOCET PT 09/30/1998
K933188 BAXTER DIAGNOSTICS, INC. DADE (PAI-1) CHROMOGENIC ASSAY DADE COAGTROL-PAI 09/22/1993
K900377 BAXTER HEALTHCARE CORP. COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN 03/06/1990
K970431 BEHRING DIAGNOSTICS, INC. BEHRING COAGULATION SYSTEM 05/05/1997
K926551 BEHRING DIAGNOSTICS, INC. BEHRING FIBRINTIMER A 04/18/1995
K924124 BEHRING DIAGNOSTICS, INC. BEHRING FIBRINTIMER A 12/01/1992
K924509 BEHRING DIAGNOSTICS, INC. CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION 12/21/1992
K924393 BEHRING DIAGNOSTICS, INC. STANDARD HUMAN PLASMA 11/16/1992
K853246 BIO/DATA CORP. CALCIUM CHLORIDE 08/13/1985
K761176 BIO/DATA CORP. CALCIUM CHLORIDE (0.025M) 01/10/1977
K853076 BIO/DATA CORP. CITREX I 08/12/1985
K853077 BIO/DATA CORP. CITREX II 08/12/1985
K853078 BIO/DATA CORP. CITREX III 08/12/1985
K761175 BIO/DATA CORP. IMIDAZOLE BUFFER (0.05M) 01/10/1977
K854546 BIO/DATA CORP. MICROSAMPLE COAGULATION ANALYSER MODEL 110P 01/07/1986
K860342 BIO/DATA CORP. MICROSAMPLE COAGULATION ANALYSER, MODEL 110WP 03/04/1986
K893650 BIO/DATA CORP. PLATELET AGGREGATION PROFILER MODEL PAP-4C 06/23/1989
K761091 BIO/DATA CORP. TPC-LYOPHILIZED POOLED HUMAN PLASMA 02/01/1977
K761173 BIO/DATA CORP. TRIS BUFFERED 01/10/1977
K761172 BIO/DATA CORP. TRIS BUFFERED SALINE 01/10/1977
K761171 BIO/DATA CORP. VERONAL BUFFER 01/10/1977
K051030 BIOMERIEUX, INC. COAG-A-MATE MTX III 12/23/2005
K050513 BIOMERIEUX, INC. MDA B.30 04/01/2005
K860719 BIOTRACK, INC. BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST) 05/23/1986
K930454 BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM COAGUCHEK SYSTEM 08/05/1993
K952625 BOEHRINGER MANNHEIM CORP. COAGUCHEK SYSTEM 11/21/1995
K974569 BOEHRINGER MANNHEIM CORP. COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING 01/09/1998
K882444 CARDIOVASCULAR DIAGNOSTIC SERVICES COAG-I ANALYZER, ALPHA MODEL 08/25/1988
K990566 CARDIOVASCULAR DIAGNOSTICS, INC. TAS ANALYZER, MODEL 1009 05/14/1999
K150041 Coramed Technologies, LLC CORA (Coagulation Resonance Analysis) System 06/26/2015
K880713 CREATIVE LABORATORY PRODUCTS, INC. CLP 0.1 M SODIUM CITRATE SOLUTION 03/18/1988
K013114 DADE BEHRING, INC. BCS SYSTEM 11/09/2001
K011665 DADE BEHRING, INC. BCT SYSTEM 08/09/2001
K000973 DADE BEHRING, INC. BEHRING COAGULATION SYSTEM (BCS) 05/26/2000
K992959 DADE BEHRING, INC. BEHRING COAGULATION SYSTEM (BCS) 01/11/2000
K002080 DADE BEHRING, INC. BEHRING COAGULATION SYSTEM, MODEL BCS 11/16/2000
K001064 DADE BEHRING, INC. BEHRING COAGULATION TIMER ANALYZER (BCT) 06/21/2000
K984501 DADE BEHRING, INC. DADE BEHRING BFTII 07/28/1999
K001067 DADE BEHRING, INC. DADE BEHRING COAGULATION ANALYZER (BCT) 06/20/2000
K023141 DADE BEHRING, INC. MODIFICATION TO STANDARD HUMAN PLASMA 01/16/2003
K011235 DADE BEHRING, INC. SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 07/20/2001
K981711 DADE BEHRING, INC. SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 09/30/1998
K010494 DADE BEHRING, INC. SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 05/01/2001
K760594 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. AUTO-FI COAGULATION INSTRUMENT 11/24/1976
K790204 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. PLASMA, STANDARDIZED NORMAL 03/12/1979
K770606 DAMON CORP. ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH 05/06/1977
K151867 DIAGNOSTICA STAGO S.A.S. STA R MAX 08/07/2015
K093167 DIAGNOSTICA STAGO, INC. STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER 12/22/2009
K082248 DIAGNOSTICA STAGO, INC. STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER 12/12/2008
K082675 DIAGNOSTICA STAGO, INC. STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER 10/10/2008
K130090 DIAGNOSTICA STAGO, INCORPORATED STA COMPACT MAX 02/12/2013
K093001 DIAGNOSTICA STAGO, INCORPORATED STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER 12/18/2009
K854938 DIATECH, INC. COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST. 03/12/1986
K854089 DIATECH, INC. DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENT 01/06/1986
K854090 DIATECH, INC. DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENT 01/06/1986
K841462 DIATECH, INC. HEPARIN COAGULATION CONTROL PLASMA 1- 06/01/1984
K841523 DIATECH, INC. OWREN'S VERONAL BUFFERR 06/01/1984
K851127 E.I. DUPONT DE NEMOURS & CO., INC. DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO 05/29/1985
K050243 FARALLON MEDIAL INC IMMEDIA PROTHROMBIN TIME SYSTEM 06/06/2005
K790323 GENERAL DIAGNOSTICS COAG-A-MATE 2001 03/21/1979
K160502 Haemonetics Corporation TEG 6s Hemostasis System 04/19/2017
K993678 HAEMOSCOPE CORP. THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES 05/05/2000
K002177 HAEMOSCOPE CORP. THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES 09/14/2000
K061014 HELENA LABORATORIES ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP 05/10/2006
K951497 HELENA LABORATORIES CASCASE 480 SNSLYZER 09/01/1995
K872377 HELENA LABORATORIES CHROM-TROL 07/09/1987
K050053 HELENA LABORATORIES HEMORAM/AGGRAM ANALYZER 07/11/2005
K792310 HELENA LABORATORIES NORM-TROL 12/04/1979
K883484 HELENA LABORATORIES OWREN'S VERONAL BUFFER 08/25/1988
K926222 HELENA LABORATORIES OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 02/12/1993
K961908 HELENA LABORATORIES THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 12/10/1996
K853789 HEMOTEC, INC. ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR 10/04/1985
K894359 HEMOTEC, INC. CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS 09/05/1989
K854376 HEMOTEC, INC. HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS 12/04/1985
K875089 HEMOTEC, INC. HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN 03/09/1988
K894466 HEMOTEC, INC. HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS 09/05/1989
K000053 INSTRUMENTATION LABORATORY CO. ACL 9000 SYSTEM 03/15/2000
K170314 INSTRUMENTATION LABORATORY CO. ACL AcuStar 03/03/2017
K083518 INSTRUMENTATION LABORATORY CO. ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS 03/13/2009
K912087 INSTRUMENTATION LABORATORY CO. ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS 09/19/1991
K060162 INSTRUMENTATION LABORATORY CO. ACL ELITE; ACL ELITE PRO 02/21/2006
K951891 INSTRUMENTATION LABORATORY CO. ACL FUTURA COAGULATION SYSTEM 11/03/1995
K881367 INSTRUMENTATION LABORATORY CO. ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS 06/27/1988
K040359 INSTRUMENTATION LABORATORY CO. HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 03/19/2004
K864271 INSTRUMENTATION LABORATORY CO. IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA 11/25/1986
K002400 INSTRUMENTATION LABORATORY CO. MODIFICATION OF ACL ADVANCE 08/30/2000
K990449 INTERNATIONAL TECHNIDYNE CORP. HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE 04/13/1999
K974799 INTERNATIONAL TECHNIDYNE CORP. HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE 07/07/1998
K020798 INTERNATIONAL TECHNIDYNE CORP. HEMOCHRON JR. SIGNATURE + 03/28/2002
K030818 INTERNATIONAL TECHNIDYNE CORP. HEMOCHRON RESPONSE/SYSTEM 04/02/2003
K050016 INTERNATIONAL TECHNIDYNE CORP. HEMOCHRON SIGNATURE ELITE 02/10/2005
K940957 INTERNATIONAL TECHNIDYNE CORP. HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM 10/18/1994
K923761 INTERNATIONAL TECHNIDYNE CORP. ITC MICROSAMPLE COAGULATION ANALYZER SYSTEM 01/21/1993
K940401 INTERNATIONAL TECHNIDYNE CORP. JR. MICROCOAGULATION SYSTEM 05/11/1994
K870831 INTERNATIONAL TECHNIDYNE CORP. PDA699/PDA700 PROTAMINE DOSE ASSAY FOR HEP. NEUTRA 06/01/1987
K071265 INVERNESS MEDICAL INNOVATIONS, INC. SMARTCHECK INR SYSTEM 11/30/2007
K883637 KING DIAGNOSTICS, INC. KD 0.02 M CALCIUM CHLORIDE SOLUTION 10/31/1988
K883635 KING DIAGNOSTICS, INC. KD 0.1 M SODIUM CITRATE SOLUTION 10/31/1988
K883640 KING DIAGNOSTICS, INC. KD ONE-STAGE PROTHROMBIN TIME TEST 10/31/1988
K852450 LODE CORP. LODE COAGULOMETER MODEL LC-6 09/30/1985
K853198 MEDICAL DEVICE CONSULTANTS, INC. ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES 10/04/1985
K864532 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. ELECTRA(R) 700 AUTOMATIC COAGULATION TIMER 02/06/1987
K864534 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. ELECTRA(R) 800 AUTOMATIC COAGULATION TIMER 02/06/1987
K812124 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. MLA ELECTRA 700 10/02/1981
K780810 MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. MLA ELECTRA 750 COAGULATION TIMER 06/14/1978
K981815 MEDTRONIC BLOOD MANAGEMENT HEPTRAC ELECTRONIC QUALITY CONTROL 07/30/1998
K954202 MEDTRONIC HEMOTEC, INC. PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS 06/20/1996
K900917 ORGANON TEKNIKA CORP. COAG-A-MATE - RA4 04/16/1990
K885076 ORGANON TEKNIKA CORP. COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE 12/30/1988
K870960 ORGANON TEKNIKA CORP. COAG-A-MATE(R) XC 03/17/1987
K924453 ORGANON TEKNIKA CORP. MULTI-CHANNEL DISCRETE ANALYZER (MDA-180) 12/18/1992
K930849 ORGANON TEKNIKA CORP. VERIFY REFERENCE PLASMA AND MDA VERIFY REF. PLASMA 04/20/1993
K853328 ORTHO DIAGNOSTIC SYSTEMS, INC. KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS 11/05/1985
K914188 ORTHO DIAGNOSTIC SYSTEMS, INC. KOAGULAB CTS CHROMOGRNIC TESTING SYSTEM 08/26/1992
K862537 ORTHO DIAGNOSTIC SYSTEMS, INC. KOAGULAB* M COAGULATION SYSTEM 07/21/1986
K832225 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO ABNORMAL COAGULATION LEVEL I/II 08/12/1983
K883689 ORTHO DIAGNOSTIC SYSTEMS, INC. ORTHO OWREN'S BUFFER 11/01/1988
K884534 PALL BIOMEDICAL PRODUCTS CO. PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER 01/24/1989
K083842 PENTAPHARM GMBH ROTEM DELTA THROMBOELASTOMETRY SYSTEM 03/23/2010
K870771 PROBE-TEK, INC. PT HEPARIN ADSORBENT 04/23/1987
K934747 R & D BATTERIES, INC. R & D BATTERIES, INC. PART NUMBERS 5296, 5479, 5351, & 5470 12/03/1993
K842717 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS-FIBRO 10/17/1984
K994349 ROCHE DIAGNOSTICS CORP. COAGUCHEK S SYSTEM, MODEL 2138280 09/06/2000
K983892 ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P 04/13/1999
K173202 Sekisui Medical Co., Ltd. CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set 05/09/2018
K172286 Siemens Healthcare Diagnostic Products Gmbh Automated Blood Coagulation Analyzer CS-2500 12/18/2017
K150678 Siemens Healthcare Diagnostic Products Gmbh Sysmex Automated Blood Coagulation Analyzer CS-5100 01/11/2016
K083159 SIEMENS HEALTHCARE DIAGNOSTICS BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2 01/26/2009
K083175 SIEMENS HEALTHCARE DIAGNOSTICS BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2 01/26/2009
K151259 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH Sysmex Automated Blood Coagulation Analyzer CS-2100i 01/26/2016
K161312 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH Sysmex Automated Blood Coagulation Analyzer CS-2100i 09/01/2016
K162420 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH Sysmex Automated Blood Coagulation Analyzer CS-5100 12/12/2016
K161317 Siemens Healthcare Diagnostics Products GmbH Sysmex Automated Blood Coagulation Analyzer CS-5100 09/02/2016
K162688 Siemens Healthcare Diagnostics Products GmbH Sysmex CS-2100i 12/26/2016
K172333 Siemens Healthcare Diagnostics Products GmbH Sysmex CS-5100 10/31/2017
K952560 SIENCO, INC. SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER 09/05/1995
K940840 SIGMA DIAGNOSTICS, INC. ACT CONTROL SET 07/19/1994
K955720 SIGMA DIAGNOSTICS, INC. AMAX CS-190 COAGULATION ANALYZER SYSTEM 03/13/1996
K021162 SIGMA DIAGNOSTICS, INC. AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED 08/30/2002
K972260 SIGMA DIAGNOSTICS, INC. CS-400 COAGULATION ANALYZER SYSTEM (A1208) 10/20/1997
K912061 SIGMA DIAGNOSTICS, INC. HEPARIN ADSORBENT 07/24/1991
K955724 SIGMA DIAGNOSTICS, INC. KC 1A COAGULATION ANALYZER/SET 03/12/1996
K960875 SIGMA DIAGNOSTICS, INC. KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) 09/10/1996
K955735 SIGMA DIAGNOSTICS, INC. KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM 03/11/1996
K964946 SYSMEX CORP. SYSMEX CA-1000/SYSMEX CA-5000 03/18/1997
K942096 SYSMEX CORP. TOA MEDICAL ELECTRONICS CA-1000 03/24/1995
K942097 SYSMEX CORP. TOA MEDICAL ELECTRONICS CA-5000 03/24/1995
K930068 TECHNIDYNE CORP. HEMOCHRON MODEL 8000/FACTOR VI PREMIER COAGULATION 09/02/1993
K101533 Tem Innovations GmbH EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM 08/10/2011
K931149 TOA MEDICAL ELECTRONICS USA, INC. CA-1000 AUTOMATED COAGULATION ANALYZER 11/03/1993
K933886 TOA MEDICAL ELECTRONICS USA, INC. TOA MEDICAL ELECTRONICS CA-5000 01/27/1994
K083896 TRINITY BIOTECH DESTINY MAX COAGULATION ANALYZER 07/02/2009
K870685 U. S. DIAGNOSTICS, INC. COAGULATION CONTROL, LEVEL I 04/20/1987
K870686 U. S. DIAGNOSTICS, INC. COAGULATION CONTROL, LEVEL II 04/20/1987
K870687 U. S. DIAGNOSTICS, INC. COAGULATION CONTROL, LEVEL III 04/20/1987
K870688 U. S. DIAGNOSTICS, INC. O.O2 M CALCIUM CHLORIDE SOLUTION 03/31/1987
K812121 VOLU SOL MEDICAL INDUSTRIES DIGICLOT 2-#820 11/16/1981
K791586 VOLU SOL MEDICAL INDUSTRIES ELVI 818 DIGICLOT MULTISCAN 09/17/1979
K812122 VOLU SOL MEDICAL INDUSTRIES MULTI CLOT-#819 11/10/1981
K033137 WADA, INC. POTENS + 12/08/2003
K850409 WARNER-LAMBERT CO. GEN. DIAG. CHROMOSTRATE REF. PLASMA 05/08/1985


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