Product code GJS— Hematology
microINR System
- Classification name
- Test, Time, Prothrombin
- Device class
- Class 2
- Regulation
- 21 CFR 864.7750
- Advisory panel
- Hematology
- Total cleared
- 127
- First cleared
- Most recent
Market context for product code GJS
FDA has cleared devices under product code GJS between 1978 and 2025, filed by 55 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2024
- 2023
- 2022
- 2020
- 2019
- 2018
- 2017
- 2016
- 2014
- 2013
- 2012
- 2010
- 2008
- 2007
Top applicants under product code GJS
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.