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 |
| K202101 | Accriva Diagnostics, Inc. | 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, Lev | 12/29/2021 |
| K193041 | Accriva Diagnostics, Inc. | Hemochron Signature Elite | 11/22/2019 |
| K983460 | AMERICAN BIOPRODUCTS CO. | STAR AUTOMATED MULTI-PARAMETRIC ANALYZER | 11/12/1998 |
| K980839 | AVOCET MEDICAL, INC. | AVOCET PT | 09/30/1998 |
| K970431 | BEHRING DIAGNOSTICS, INC. | BEHRING COAGULATION SYSTEM | 05/05/1997 |
| K051030 | BIOMERIEUX, INC. | COAG-A-MATE MTX III | 12/23/2005 |
| K050513 | BIOMERIEUX, INC. | MDA B.30 | 04/01/2005 |
| K974569 | BOEHRINGER MANNHEIM CORP. | COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING | 01/09/1998 |
| K990566 | CARDIOVASCULAR DIAGNOSTICS, INC. | TAS ANALYZER, MODEL 1009 | 05/14/1999 |
| K150041 | Coramed Technologies, LLC | CORA (Coagulation Resonance Analysis) System | 06/26/2015 |
| 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 |
| K183390 | Diagnostic Grifols, S.A. | QNext and DG-PT | 08/21/2019 |
| K151867 | DIAGNOSTICA STAGO S.A.S. | STA R MAX | 08/07/2015 |
| K212183 | Diagnostica Stago SAS | STA R Max 3, STA Compact Max 3 | 06/07/2023 |
| 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 |
| K050243 | FARALLON MEDIAL INC | IMMEDIA PROTHROMBIN TIME SYSTEM | 06/06/2005 |
| K160502 | Haemonetics Corporation | TEG 6s Hemostasis System | 04/19/2017 |
| K183160 | Haemonetics Corporation | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge | 05/09/2019 |
| 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 |
| K050053 | HELENA LABORATORIES | HEMORAM/AGGRAM ANALYZER | 07/11/2005 |
| K961908 | HELENA LABORATORIES | THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 | 12/10/1996 |
| 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 |
| K060162 | INSTRUMENTATION LABORATORY CO. | ACL ELITE; ACL ELITE PRO | 02/21/2006 |
| K221359 | Instrumentation Laboratory Co. | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-▀2 Glycoprotein-I IgM | 09/29/2023 |
| K040359 | INSTRUMENTATION LABORATORY CO. | HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 | 03/19/2004 |
| 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 |
| K071265 | INVERNESS MEDICAL INNOVATIONS, INC. | SMARTCHECK INR SYSTEM | 11/30/2007 |
| 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 |
| K083842 | PENTAPHARM GMBH | ROTEM DELTA THROMBOELASTOMETRY SYSTEM | 03/23/2010 |
| 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 |
| 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 |
| 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 |
| K101533 | Tem Innovations GmbH | EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM | 08/10/2011 |
| K201440 | Tem Innovations GmbH | ROTEM sigma Thromboelastometry System | 07/08/2022 |
| K083896 | TRINITY BIOTECH | DESTINY MAX COAGULATION ANALYZER | 07/02/2009 |
| K033137 | WADA, INC. | POTENS + | 12/08/2003 |
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