FDA 510(k) Applications for Medical Device Product Code "GJS"
(Test, Time, Prothrombin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220282 | Abbott Laboratories | i-STAT PTplus Cartridge with the i-STAT 1 System | 07/14/2023 |
| K110212 | ALERE SAN DIEGO, INC (FORMALLY BIOSITE INCORPORATE | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP | 05/01/2012 |
| K052124 | AMERICAN DIAGNOSTICA, INC. | ACTICLOT, MODEL 824 | 10/17/2005 |
| K994006 | AVOCET MEDICAL, INC. | AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) | 02/03/2000 |
| K991286 | AVOCET MEDICAL, INC. | AVOCET ACUSURE SYSTEM | 11/18/1999 |
| K092987 | BIOSITE INCORPORATED | INRATIO/INRATIO2 TEST STRIPS | 06/11/2010 |
| K962571 | BOEHRINGER MANNHEIM CORP. | COAGUCHEK PST SYSTEM | 04/22/1997 |
| K955843 | CARDIOVASCULAR DIAGNOSTIC SERVICES | TAS PTONE | 03/18/1996 |
| K954625 | CARDIOVASCULAR DIAGNOSTICS, INC. | PROTHROMBIN TIME TEST CARD | 03/11/1996 |
| K991065 | CARESIDE, INC. | CARESIDE PT | 07/26/1999 |
| K093243 | COAGUSENSE, INC | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM | 04/07/2010 |
| K212779 | CoaguSense, Inc. | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | 10/05/2022 |
| K183255 | CoaguSense, Inc. | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | 02/21/2019 |
| K013155 | DADE BEHRING, INC. | DADE THROMBOPLASTIN C PLUS | 01/18/2002 |
| K003870 | DADE BEHRING, INC. | THROMBOREL S | 02/20/2001 |
| K974343 | DADE INTL., INC. | DADE INNOVIN | 07/22/1998 |
| K211485 | Diagnostica Stago SAS | STA- NeoPTimal | 12/23/2022 |
| K020679 | HEMOSENSE, INC. | INRATIO | 05/06/2002 |
| K072727 | HEMOSENSE, INC. | INRATIO 2 PT MONITORING SYSTEM | 10/26/2007 |
| K021923 | HEMOSENSE, INC. | INRATIO SELF-TEST | 10/24/2002 |
| K020355 | I-STAT CORPORATION | I-STAT PROTHROMBIN TIME TEST | 05/14/2002 |
| K251564 | iLine Microsystems S.L. | microINR System | 07/21/2025 |
| K243543 | iLine Microsystems S.L. | microINR System | 02/27/2025 |
| K201185 | iLine Microsystems S.L. | microINR System | 12/18/2020 |
| K231711 | iLine Microsystems S.L. | microINR System | 07/11/2023 |
| K180780 | iLine Microsystems S.L. | microINR System | 01/25/2019 |
| K060931 | INSTRUMENTATION LABORATORY CO. | HEMOSIL PT-FIBRINOGEN HS PLUS | 05/02/2006 |
| K122584 | INSTRUMENTATION LABORATORY CO. | HEMOSIL READIPLAS TIN | 03/24/2013 |
| K213426 | Instrumentation Laboratory Co. | HemosIL ReadiPlasTin | 08/16/2022 |
| K012768 | INSTRUMENTATION LABORATORY CO. | HEMOSIL RECOMBI PLASTIN | 09/18/2001 |
| K043184 | INSTRUMENTATION LABORATORY CO. | HEMOSIL RECOMBIPLASTIN | 12/22/2004 |
| K070005 | INSTRUMENTATION LABORATORY CO. | HEMOSIL RECOMBIPLASTIN 2G | 08/15/2007 |
| K132722 | INSTRUMENTATION LABORATORY CO. | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | 01/22/2014 |
| K981479 | INSTRUMENTATION LABORATORY CO. | IL TEST PT-FIBRINOGEN RECOMBINANT | 07/07/1998 |
| K972866 | INTERNATIONAL TECHNIDYNE CORP. | HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT | 09/30/1998 |
| K961835 | INTERNATIONAL TECHNIDYNE CORP. | PROTIME MICROCOAGULATION SYSTEM | 03/12/1997 |
| K010599 | INTERNATIONAL TECHNIDYNE CORP. | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE | 07/02/2001 |
| K022922 | LIFESCAN, INC. | HARMONY INR MONITORING SYSTEM | 09/30/2002 |
| K001699 | LIFESCAN, INC. | RUBICON PROTHROMBIN TIME MONITORING SYSTEM | 05/15/2001 |
| K961938 | NOVA BIOMEDICAL CORP. | STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS | 06/28/1996 |
| K974566 | ORGANON TEKNIKA CORP. | MDA SIMPLASTIN HTF | 02/24/1998 |
| K994100 | PACIFIC HEMOSTASIS | PACIFIC HEMOSTASIS THROMBOPLASTIN D | 02/18/2000 |
| K040296 | R2 DIAGNOSTICS, INC. | PHOSPHOPLASTIN RL | 05/24/2004 |
| K170960 | Roche Diagnostics | CoaguChek Vantus System | 12/25/2017 |
| K180684 | Roche Diagnostics | CoaguChek XS Plus System | 04/19/2018 |
| K071041 | Roche Diagnostics | COAGUCHEK XS PLUS SYSTEM | 05/11/2007 |
| K180693 | Roche Diagnostics | CoaguChek XS Pro System | 04/19/2018 |
| K093460 | Roche Diagnostics | COAGUCHEK XS PRO SYSTEM | 03/18/2010 |
| K060978 | Roche Diagnostics | COAGUCHEK XS SYSTEM | 08/11/2006 |
| K030845 | ROCHE DIAGNOSTICS CORP. | COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING | 05/22/2003 |
| K092940 | ROCHE DIAGNOSTICS CORP. | COAGUCHEK XS PLUS PST SYSTEM | 03/05/2010 |
| K062925 | ROCHE DIAGNOSTICS CORP. | COAGUCHEK XS SYSTEM | 01/29/2007 |
| K072920 | ROCHE DIAGNOSTICS CORP. | HANDHELD BASE UNIT | 01/31/2008 |
| K020831 | ROCHE DIAGNOSTICS CORP. | PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 | 10/24/2002 |
| K021190 | ROCHE DIAGNOSTICS CORP. | PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 | 10/25/2002 |
| K992492 | ROCHE DIAGNOSTICS CORP. | PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM | 11/02/1999 |
| K151964 | SIEMENS HEALTHCARE DIAGNOSTICS | Xprecia Stride Coagulation System, Xprecia System PT Controls | 09/30/2016 |
| K972796 | SIGMA DIAGNOSTICS, INC. | SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM | 10/10/1997 |
| K230802 | Universal Biosensors Pty Ltd | Xprecia Prime Coagulation System | 03/15/2024 |
| K020840 | VITAL SCIENTIFIC N.V. | VITAL SCIENTIFIC PT WITH CALCIUM | 05/15/2002 |
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