Panels › Hematology › Product code GJS · Class 2
Test, Time, Prothrombin
Regulation 864.7750
0510(k)s in 12 months (127 all time)
0recalls in 12 months (73 all time)
68recalls that name a 510(k)
Top companies in GJS
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 24, 2025 | K253188 | CoaguChek XS Plus System Roche Diagnostics | GJS |
| Jul 21, 2025 | K251564 | microINR System Iline Microsystems, S.L., ES | GJS |
| Feb 27, 2025 | K243543 | microINR System Iline Microsystems, S.L., ES | GJS |
| Mar 15, 2024 | K230802 | Xprecia Prime Coagulation System Universal Biosensors Pty, Ltd., AU | GJS |
| Jul 14, 2023 | K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System Abbott Laboratories | GJS |
| Jul 11, 2023 | K231711 | microINR System Iline Microsystems, S.L., ES | GJS |
| Dec 23, 2022 | K211485 | STA- NeoPTimal Diagnostica Stago S.A.S, FR | GJS |
| Oct 5, 2022 | K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing Coagusense, Inc. | GJS |
| Aug 16, 2022 | K213426 | HemosIL ReadiPlasTin Instrumentation Laboratory CO | GJS |
| Dec 18, 2020 | K201185 | microINR System Iline Microsystems, S.L., ES | GJS |
| Feb 21, 2019 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device Coagusense, Inc. | GJS |
| Jan 25, 2019 | K180780 | microINR System Iline Microsystems, S.L., ES | GJS |
| Apr 19, 2018 | K180693 | CoaguChek XS Pro System Roche Diagnostics | GJS |
| Apr 19, 2018 | K180684 | CoaguChek XS Plus System Roche Diagnostics | GJS |
| Dec 25, 2017 | K170960 | CoaguChek Vantus System Roche Diagnostics | GJS |
| Sep 30, 2016 | K151964 | Xprecia Stride Coagulation System, Xprecia System PT Controls Siemens Healthcare Diagnostics | GJS |
| Jan 22, 2014 | K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) Instrumentation Laboratory CO | GJS |
| Mar 24, 2013 | K122584 | HEMOSIL READIPLAS TIN Instrumentation Laboratory CO | GJS |
| May 1, 2012 | K110212 | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP Alere San Diego, Inc (Formally Biosite Incorporate | GJS |
| Jun 11, 2010 | K092987 | INRATIO/INRATIO2 TEST STRIPS Biosite Incorporated | GJS |
| Apr 7, 2010 | K093243 | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM Coagusense, Inc. | GJS |
| Mar 18, 2010 | K093460 | COAGUCHEK XS PRO SYSTEM Roche Diagnostics | GJS |
| Mar 5, 2010 | K092940 | COAGUCHEK XS PLUS PST SYSTEM Roche Diagnostics Corp. | GJS |
| Jan 31, 2008 | K072920 | HANDHELD BASE UNIT Roche Diagnostics Corp. | GJS |
| Oct 26, 2007 | K072727 | INRATIO 2 PT MONITORING SYSTEM Hemosense, Inc. | GJS |
| Aug 15, 2007 | K070005 | HEMOSIL RECOMBIPLASTIN 2G Instrumentation Laboratory CO | GJS |
| May 11, 2007 | K071041 | COAGUCHEK XS PLUS SYSTEM Roche Diagnostics | GJS |
| Jan 29, 2007 | K062925 | COAGUCHEK XS SYSTEM Roche Diagnostics Corp. | GJS |
| Aug 11, 2006 | K060978 | COAGUCHEK XS SYSTEM Roche Diagnostics | GJS |
| May 2, 2006 | K060931 | HEMOSIL PT-FIBRINOGEN HS PLUS Instrumentation Laboratory CO | GJS |
| Oct 17, 2005 | K052124 | ACTICLOT, MODEL 824 American Diagnostica, Inc. | GJS |
| Dec 22, 2004 | K043184 | HEMOSIL RECOMBIPLASTIN Instrumentation Laboratory CO | GJS |
| May 24, 2004 | K040296 | PHOSPHOPLASTIN RL R2 Diagnostics, Inc. | GJS |
| May 22, 2003 | K030845 | COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING Roche Diagnostics Corp. | GJS |
| Oct 25, 2002 | K021190 | PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 Roche Diagnostics Corp. | GJS |
| Oct 24, 2002 | K021923 | INRATIO SELF-TEST Hemosense, Inc. | GJS |
| Oct 24, 2002 | K020831 | PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 Roche Diagnostics Corp. | GJS |
| Sep 30, 2002 | K022922 | HARMONY INR MONITORING SYSTEM Lifescan, Inc. | GJS |
| May 15, 2002 | K020840 | VITAL SCIENTIFIC PT WITH CALCIUM Vital Scientific N.V. | GJS |
| May 14, 2002 | K020355 | I-STAT PROTHROMBIN TIME TEST I-Stat Corporation | GJS |
| May 6, 2002 | K020679 | INRATIO Hemosense, Inc. | GJS |
| Jan 18, 2002 | K013155 | DADE THROMBOPLASTIN C PLUS Dade Behring, Inc. | GJS |
| Sep 18, 2001 | K012768 | HEMOSIL RECOMBI PLASTIN Instrumentation Laboratory CO | GJS |
| Jul 2, 2001 | K010599 | PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE International Technidyne Corp. | GJS |
| May 15, 2001 | K001699 | RUBICON PROTHROMBIN TIME MONITORING SYSTEM Lifescan, Inc. | GJS |
| Feb 20, 2001 | K003870 | THROMBOREL S Dade Behring, Inc. | GJS |
| Feb 18, 2000 | K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D Pacific Hemostasis | GJS |
| Feb 3, 2000 | K994006 | AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) Avocet Medical, Inc. | GJS |
| Nov 18, 1999 | K991286 | AVOCET ACUSURE SYSTEM Avocet Medical, Inc. | GJS |
| Nov 2, 1999 | K992492 | PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM Roche Diagnostics Corp. | GJS |
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