GJS
microINR System
- Advisory panel
- Hematology
- Total cleared
- 127
Adverse events under product code GJS
product code GJS- Death
- 4
- Injury
- 229
- Malfunction
- 4,852
- Total
- 5,085
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GJS
1–100 of 127- K253188 — CoaguChek XS Plus System
- K251564 — microINR System
- K243543 — microINR System
- K230802 — Xprecia Prime Coagulation System
- K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System
- K231711 — microINR System
- K211485 — STA- NeoPTimal
- K212779 — Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing
- K213426 — HemosIL ReadiPlasTin
- K201185 — microINR System
- K183255 — Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
- K180780 — microINR System
- K180684 — CoaguChek XS Plus System
- K180693 — CoaguChek XS Pro System
- K170960 — CoaguChek Vantus System
- K151964 — Xprecia Stride Coagulation System, Xprecia System PT Controls
- K132722 — HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL)
- K122584 — HEMOSIL READIPLAS TIN
- K110212 — INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP
- K092987 — INRATIO/INRATIO2 TEST STRIPS
- K093243 — COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
- K093460 — COAGUCHEK XS PRO SYSTEM
- K092940 — COAGUCHEK XS PLUS PST SYSTEM
- K072920 — HANDHELD BASE UNIT
- K072727 — INRATIO 2 PT MONITORING SYSTEM
- K070005 — HEMOSIL RECOMBIPLASTIN 2G
- K071041 — COAGUCHEK XS PLUS SYSTEM
- K062925 — COAGUCHEK XS SYSTEM
- K060978 — COAGUCHEK XS SYSTEM
- K060931 — HEMOSIL PT-FIBRINOGEN HS PLUS
- K052124 — ACTICLOT, MODEL 824
- K043184 — HEMOSIL RECOMBIPLASTIN
- K040296 — PHOSPHOPLASTIN RL
- K030845 — COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
- K021190 — PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
- K020831 — PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
- K021923 — INRATIO SELF-TEST
- K022922 — HARMONY INR MONITORING SYSTEM
- K020840 — VITAL SCIENTIFIC PT WITH CALCIUM
- K020355 — I-STAT PROTHROMBIN TIME TEST
- K020679 — INRATIO
- K013155 — DADE THROMBOPLASTIN C PLUS
- K012768 — HEMOSIL RECOMBI PLASTIN
- K010599 — PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
- K001699 — RUBICON PROTHROMBIN TIME MONITORING SYSTEM
- K003870 — THROMBOREL S
- K994100 — PACIFIC HEMOSTASIS THROMBOPLASTIN D
- K994006 — AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
- K991286 — AVOCET ACUSURE SYSTEM
- K992492 — PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
- K991065 — CARESIDE PT
- K972866 — HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
- K974343 — DADE INNOVIN
- K981479 — IL TEST PT-FIBRINOGEN RECOMBINANT
- K974566 — MDA SIMPLASTIN HTF
- K972796 — SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
- K962571 — COAGUCHEK PST SYSTEM
- K961835 — PROTIME MICROCOAGULATION SYSTEM
- K961938 — STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
- K955843 — TAS PTONE
- K954625 — PROTHROMBIN TIME TEST CARD
- K951820 — THROMBOPLASTIN-LI REAGENT
- K952608 — MDA SIMPLASTIN LS
- K942884 — COAGUCHEK SYSTEM
- K945078 — HEMOCHRON HNPT/FACTOR VI PT+
- K935748 — ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT
- K940082 — THROMBOSCREEN THROMBOPLASTIN-DS
- K935702 — DADE INNOVIN II
- K940432 — MICROCOAGULATION PROTHROMBIN TIME TEST
- K940310 — HELENA THROMBOPLASTIN-MI REAGENT
- K931117 — ASSESS(TM) LOW ABNORMAL CONTROL
- K931118 — ASSESS(TM) HIGH ABNORMAL CONTROL
- K933252 — IL TEST (TM) PT-FIBRINOGEN HS PLUS
- K930212 — THROMBOPLATIN-M WITH CALCIUM
- K925604 — ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT
- K920767 — NYCOPLASTIN
- K925492 — BIOMERIEUX HEMOLAB THROMBOMAT
- K922565 — NEOPLASTINE(R) CI KIT
- K921326 — DADE RECOMBOPLASTIN S
- K922040 — NEOPLASTINE CI PLUS
- K915746 — SIMPLASTIN L
- K913249 — ACS ULTRA-1 THROMBOPLASTIN
- K913250 — ACS ULTRA-2 THROMBOPLASTIN
- K912102 — ACS LIQUID THROMBOPLASTIN
- K911995 — PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
- K905807 — HELENA THROMBOPLASTIN REAGENT WITH DILUENT
- K905857 — HELENA THROMBOPLASTIN REAGENT, MODIFICATION
- K904325 — COAG-1 PT-NC TEST CARD
- K904454 — HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION
- K902468 — ACS ONE-STAGE PROTHROMBIN TIME REAGENT
- K903019 — MODIFIED COAG-1 PT TEST CARD
- K902096 — THROMBOPLASTIN WITH CALCIUM
- K901325 — THROMBOPLASTIN.C PLUS
- K896625 — THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.
- K885107 — THROMBOSTIN IFA*
- K893378 — PROTHROMBIN TIME (PT) BY HEMOCHRON
- K892050 — HELENA THROMBOPLASTIN REAGENT
- K891370 — EDL ONE-STAGE PROTHROMBIN TIME REAGENT
- K891169 — DADE THROMBOPLASTIN IS
- K884855 — THROMBOPLASTIN
Data sourced from openFDA. This site is unofficial and independent of the FDA.