| CoaguChek XS Plus System (K253188) | Roche Diagnostics | 2025-10-24 |
| microINR System (K251564) | Iline Microsystems, S.L. | 2025-07-21 |
| microINR System (K243543) | Iline Microsystems, S.L. | 2025-02-27 |
| Xprecia Prime Coagulation System (K230802) | Universal Biosensors Pty, Ltd. | 2024-03-15 |
| i-STAT PTplus Cartridge with the i-STAT 1 System (K220282) | Abbott Laboratories | 2023-07-14 |
| microINR System (K231711) | Iline Microsystems, S.L. | 2023-07-11 |
| STA- NeoPTimal (K211485) | Diagnostica Stago S.A.S | 2022-12-23 |
| Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (K212779) | Coagusense, Inc. | 2022-10-05 |
| HemosIL ReadiPlasTin (K213426) | Instrumentation Laboratory CO | 2022-08-16 |
| microINR System (K201185) | Iline Microsystems, S.L. | 2020-12-18 |
| Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (K183255) | Coagusense, Inc. | 2019-02-21 |
| microINR System (K180780) | Iline Microsystems, S.L. | 2019-01-25 |
| CoaguChek XS Plus System (K180684) | Roche Diagnostics | 2018-04-19 |
| CoaguChek XS Pro System (K180693) | Roche Diagnostics | 2018-04-19 |
| CoaguChek Vantus System (K170960) | Roche Diagnostics | 2017-12-25 |
| Xprecia Stride Coagulation System, Xprecia System PT Controls (K151964) | Siemens Healthcare Diagnostics | 2016-09-30 |
| HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) (K132722) | Instrumentation Laboratory CO | 2014-01-22 |
| HEMOSIL READIPLAS TIN (K122584) | Instrumentation Laboratory CO | 2013-03-24 |
| INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP (K110212) | Alere San Diego, Inc (Formally Biosite Incorporate | 2012-05-01 |
| INRATIO/INRATIO2 TEST STRIPS (K092987) | Biosite Incorporated | 2010-06-11 |
| COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM (K093243) | Coagusense, Inc. | 2010-04-07 |
| COAGUCHEK XS PRO SYSTEM (K093460) | Roche Diagnostics | 2010-03-18 |
| COAGUCHEK XS PLUS PST SYSTEM (K092940) | Roche Diagnostics Corp. | 2010-03-05 |
| HANDHELD BASE UNIT (K072920) | Roche Diagnostics Corp. | 2008-01-31 |
| INRATIO 2 PT MONITORING SYSTEM (K072727) | Hemosense, Inc. | 2007-10-26 |
| HEMOSIL RECOMBIPLASTIN 2G (K070005) | Instrumentation Laboratory CO | 2007-08-15 |
| COAGUCHEK XS PLUS SYSTEM (K071041) | Roche Diagnostics | 2007-05-11 |
| COAGUCHEK XS SYSTEM (K062925) | Roche Diagnostics Corp. | 2007-01-29 |
| COAGUCHEK XS SYSTEM (K060978) | Roche Diagnostics | 2006-08-11 |
| HEMOSIL PT-FIBRINOGEN HS PLUS (K060931) | Instrumentation Laboratory CO | 2006-05-02 |
| ACTICLOT, MODEL 824 (K052124) | American Diagnostica, Inc. | 2005-10-17 |
| HEMOSIL RECOMBIPLASTIN (K043184) | Instrumentation Laboratory CO | 2004-12-22 |
| PHOSPHOPLASTIN RL (K040296) | R2 Diagnostics, Inc. | 2004-05-24 |
| COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING (K030845) | Roche Diagnostics Corp. | 2003-05-22 |
| PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 (K021190) | Roche Diagnostics Corp. | 2002-10-25 |
| INRATIO SELF-TEST (K021923) | Hemosense, Inc. | 2002-10-24 |
| PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 (K020831) | Roche Diagnostics Corp. | 2002-10-24 |
| HARMONY INR MONITORING SYSTEM (K022922) | Lifescan, Inc. | 2002-09-30 |
| VITAL SCIENTIFIC PT WITH CALCIUM (K020840) | Vital Scientific N.V. | 2002-05-15 |
| I-STAT PROTHROMBIN TIME TEST (K020355) | I-Stat Corporation | 2002-05-14 |
| INRATIO (K020679) | Hemosense, Inc. | 2002-05-06 |
| DADE THROMBOPLASTIN C PLUS (K013155) | Dade Behring, Inc. | 2002-01-18 |
| HEMOSIL RECOMBI PLASTIN (K012768) | Instrumentation Laboratory CO | 2001-09-18 |
| PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE (K010599) | International Technidyne Corp. | 2001-07-02 |
| RUBICON PROTHROMBIN TIME MONITORING SYSTEM (K001699) | Lifescan, Inc. | 2001-05-15 |
| THROMBOREL S (K003870) | Dade Behring, Inc. | 2001-02-20 |
| PACIFIC HEMOSTASIS THROMBOPLASTIN D (K994100) | Pacific Hemostasis | 2000-02-18 |
| AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) (K994006) | Avocet Medical, Inc. | 2000-02-03 |
| AVOCET ACUSURE SYSTEM (K991286) | Avocet Medical, Inc. | 1999-11-18 |
| PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM (K992492) | Roche Diagnostics Corp. | 1999-11-02 |
| CARESIDE PT (K991065) | Careside, Inc. | 1999-07-26 |
| HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT (K972866) | International Technidyne Corp. | 1998-09-30 |
| DADE INNOVIN (K974343) | Dade Intl., Inc. | 1998-07-22 |
| IL TEST PT-FIBRINOGEN RECOMBINANT (K981479) | Instrumentation Laboratory CO | 1998-07-07 |
| MDA SIMPLASTIN HTF (K974566) | Organon Teknika Corp. | 1998-02-24 |
| SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM (K972796) | Sigma Diagnostics, Inc. | 1997-10-10 |
| COAGUCHEK PST SYSTEM (K962571) | Boehringer Mannheim Corp. | 1997-04-22 |
| PROTIME MICROCOAGULATION SYSTEM (K961835) | International Technidyne Corp. | 1997-03-12 |
| STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS (K961938) | Nova Biomedical Corp. | 1996-06-28 |
| TAS PTONE (K955843) | Cardiovascular Diagnostic Services | 1996-03-18 |
| PROTHROMBIN TIME TEST CARD (K954625) | Cardiovascular Diagnostics, Inc. | 1996-03-11 |
| THROMBOPLASTIN-LI REAGENT (K951820) | Helena Laboratories | 1995-10-20 |
| MDA SIMPLASTIN LS (K952608) | Organon Teknika Corp. | 1995-10-06 |
| COAGUCHEK SYSTEM (K942884) | Boehringer Mannheim Corp. | 1995-05-11 |
| HEMOCHRON HNPT/FACTOR VI PT+ (K945078) | International Technidyne Corp. | 1995-04-28 |
| ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT (K935748) | Ortho Diagnostic Systems, Inc. | 1995-04-26 |
| THROMBOSCREEN THROMBOPLASTIN-DS (K940082) | Pacific Hemostasis | 1995-02-14 |
| DADE INNOVIN II (K935702) | Baxter Diagnostics, Inc. | 1994-11-22 |
| MICROCOAGULATION PROTHROMBIN TIME TEST (K940432) | International Technidyne Corp. | 1994-05-18 |
| HELENA THROMBOPLASTIN-MI REAGENT (K940310) | Helena Laboratories | 1994-04-20 |
| ASSESS(TM) LOW ABNORMAL CONTROL (K931117) | Instrumentation Laboratory CO | 1994-03-30 |
| ASSESS(TM) HIGH ABNORMAL CONTROL (K931118) | Instrumentation Laboratory CO | 1994-03-30 |
| IL TEST (TM) PT-FIBRINOGEN HS PLUS (K933252) | Instrumentation Laboratory CO | 1993-10-04 |
| THROMBOPLATIN-M WITH CALCIUM (K930212) | Sigma Diagnostics, Inc. | 1993-05-11 |
| ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT (K925604) | Ortho Diagnostic Systems, Inc. | 1993-03-12 |
| NYCOPLASTIN (K920767) | Nycomed Pharma AS | 1993-02-12 |
| BIOMERIEUX HEMOLAB THROMBOMAT (K925492) | Biomerieux Vitek, Inc. | 1993-02-03 |
| NEOPLASTINE(R) CI KIT (K922565) | American Bioproducts Co. | 1992-12-07 |
| DADE RECOMBOPLASTIN S (K921326) | Baxter Diagnostics, Inc. | 1992-07-27 |
| NEOPLASTINE CI PLUS (K922040) | American Bioproducts Co. | 1992-06-23 |
| SIMPLASTIN L (K915746) | Organon Teknika Corp. | 1992-02-12 |
| ACS ULTRA-1 THROMBOPLASTIN (K913249) | Analytical Control Systems, Inc. | 1991-12-04 |
| ACS ULTRA-2 THROMBOPLASTIN (K913250) | Analytical Control Systems, Inc. | 1991-11-27 |
| ACS LIQUID THROMBOPLASTIN (K912102) | Analytical Control Systems, Inc. | 1991-08-09 |
| PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION (K911995) | International Technidyne Corp. | 1991-07-17 |
| HELENA THROMBOPLASTIN REAGENT WITH DILUENT (K905807) | Helena Laboratories | 1991-04-16 |
| HELENA THROMBOPLASTIN REAGENT, MODIFICATION (K905857) | Helena Laboratories | 1991-02-27 |
| COAG-1 PT-NC TEST CARD (K904325) | Cardiovascular Diagnostic Services | 1991-01-25 |
| HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION (K904454) | International Technidyne Corp. | 1990-12-17 |
| ACS ONE-STAGE PROTHROMBIN TIME REAGENT (K902468) | Analytical Control Systems, Inc. | 1990-08-10 |
| MODIFIED COAG-1 PT TEST CARD (K903019) | Cardiovascular Diagnostic Services | 1990-08-01 |
| THROMBOPLASTIN WITH CALCIUM (K902096) | Sigma Chemical Co. | 1990-07-03 |
| THROMBOPLASTIN.C PLUS (K901325) | Baxter Healthcare Corp | 1990-05-02 |
| THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER. (K896625) | Medical Diagnostic Technologies, Inc. | 1989-12-11 |
| THROMBOSTIN IFA* (K885107) | Investigacion Farmaceutica S.A. DE C.V. | 1989-06-23 |
| PROTHROMBIN TIME (PT) BY HEMOCHRON (K893378) | International Technidyne Corp. | 1989-06-22 |
| HELENA THROMBOPLASTIN REAGENT (K892050) | Helena Laboratories | 1989-06-07 |
| EDL ONE-STAGE PROTHROMBIN TIME REAGENT (K891370) | Elite Diagnostic , Ltd. | 1989-04-21 |
| DADE THROMBOPLASTIN IS (K891169) | Baxter Healthcare Corp | 1989-04-10 |
| THROMBOPLASTIN (K884855) | Precision Biologicals, Inc. | 1989-01-30 |