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Test, Time, Prothrombin

FDA product code GJS · 126 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.7750
Review panel: HE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-03-27 – 2025-10-24

GJS 2025-10-24

CoaguChek XS Plus System

Applicant Roche Diagnostics

K number K253188

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GJS 2025-07-21

microINR System

Applicant Iline Microsystems, S.L.

K number K251564

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GJS 2025-02-27

microINR System

Applicant Iline Microsystems, S.L.

K number K243543

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GJS 2024-03-15

Xprecia Prime Coagulation System

Applicant Universal Biosensors Pty, Ltd.

K number K230802

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GJS 2023-07-14

i-STAT PTplus Cartridge with the i-STAT 1 System

Applicant Abbott Laboratories

K number K220282

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GJS 2023-07-11

microINR System

Applicant Iline Microsystems, S.L.

K number K231711

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GJS 2022-12-23

STA- NeoPTimal

Applicant Diagnostica Stago S.A.S

K number K211485

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GJS 2022-10-05

Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing

Applicant Coagusense, Inc.

K number K212779

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GJS 2022-08-16

HemosIL ReadiPlasTin

Applicant Instrumentation Laboratory CO

K number K213426

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GJS 2020-12-18

microINR System

Applicant Iline Microsystems, S.L.

K number K201185

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GJS 2019-02-21

Coag-Sense Prothrombin Time (PT) / INR Monitoring Device

Applicant Coagusense, Inc.

K number K183255

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GJS 2019-01-25

microINR System

Applicant Iline Microsystems, S.L.

K number K180780

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GJS 2018-04-19

CoaguChek XS Pro System

Applicant Roche Diagnostics

K number K180693

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GJS 2018-04-19

CoaguChek XS Plus System

Applicant Roche Diagnostics

K number K180684

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GJS 2017-12-25

CoaguChek Vantus System

Applicant Roche Diagnostics

K number K170960

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GJS 2016-09-30

Xprecia Stride Coagulation System, Xprecia System PT Controls

Applicant Siemens Healthcare Diagnostics

K number K151964

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GJS 2013-03-24

HEMOSIL READIPLAS TIN

Applicant Instrumentation Laboratory CO

K number K122584

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GJS 2012-05-01

INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP

Applicant Alere San Diego, Inc (Formally Biosite Incorporate

K number K110212

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GJS 2010-06-11

INRATIO/INRATIO2 TEST STRIPS

Applicant Biosite Incorporated

K number K092987

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GJS 2010-04-07

COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM

Applicant Coagusense, Inc.

K number K093243

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GJS 2010-03-18

COAGUCHEK XS PRO SYSTEM

Applicant Roche Diagnostics

K number K093460

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GJS 2010-03-05

COAGUCHEK XS PLUS PST SYSTEM

Applicant Roche Diagnostics Corp.

K number K092940

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GJS 2008-01-31

HANDHELD BASE UNIT

Applicant Roche Diagnostics Corp.

K number K072920

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GJS 2007-10-26

INRATIO 2 PT MONITORING SYSTEM

Applicant Hemosense, Inc.

K number K072727

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GJS 2007-08-15

HEMOSIL RECOMBIPLASTIN 2G

Applicant Instrumentation Laboratory CO

K number K070005

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GJS 2007-05-11

COAGUCHEK XS PLUS SYSTEM

Applicant Roche Diagnostics

K number K071041

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GJS 2007-01-29

COAGUCHEK XS SYSTEM

Applicant Roche Diagnostics Corp.

K number K062925

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GJS 2006-08-11

COAGUCHEK XS SYSTEM

Applicant Roche Diagnostics

K number K060978

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GJS 2006-05-02

HEMOSIL PT-FIBRINOGEN HS PLUS

Applicant Instrumentation Laboratory CO

K number K060931

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GJS 2005-10-17

ACTICLOT, MODEL 824

Applicant American Diagnostica, Inc.

K number K052124

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GJS 2004-12-22

HEMOSIL RECOMBIPLASTIN

Applicant Instrumentation Laboratory CO

K number K043184

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GJS 2004-05-24

PHOSPHOPLASTIN RL

Applicant R2 Diagnostics, Inc.

K number K040296

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GJS 2003-05-22

COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING

Applicant Roche Diagnostics Corp.

K number K030845

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GJS 2002-10-25

PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422

Applicant Roche Diagnostics Corp.

K number K021190

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GJS 2002-10-24

INRATIO SELF-TEST

Applicant Hemosense, Inc.

K number K021923

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GJS 2002-10-24

PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404

Applicant Roche Diagnostics Corp.

K number K020831

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GJS 2002-09-30

HARMONY INR MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K022922

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GJS 2002-05-15

VITAL SCIENTIFIC PT WITH CALCIUM

Applicant Vital Scientific N.V.

K number K020840

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GJS 2002-05-14

I-STAT PROTHROMBIN TIME TEST

Applicant I-Stat Corporation

K number K020355

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GJS 2002-05-06

INRATIO

Applicant Hemosense, Inc.

K number K020679

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GJS 2002-01-18

DADE THROMBOPLASTIN C PLUS

Applicant Dade Behring, Inc.

K number K013155

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GJS 2001-09-18

HEMOSIL RECOMBI PLASTIN

Applicant Instrumentation Laboratory CO

K number K012768

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GJS 2001-07-02

PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE

Applicant International Technidyne Corp.

K number K010599

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GJS 2001-05-15

RUBICON PROTHROMBIN TIME MONITORING SYSTEM

Applicant Lifescan, Inc.

K number K001699

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GJS 2001-02-20

THROMBOREL S

Applicant Dade Behring, Inc.

K number K003870

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GJS 2000-02-18

PACIFIC HEMOSTASIS THROMBOPLASTIN D

Applicant Pacific Hemostasis

K number K994100

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GJS 2000-02-03

AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)

Applicant Avocet Medical, Inc.

K number K994006

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GJS 1999-11-18

AVOCET ACUSURE SYSTEM

Applicant Avocet Medical, Inc.

K number K991286

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GJS 1999-11-02

PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM

Applicant Roche Diagnostics Corp.

K number K992492

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GJS 1999-07-26

CARESIDE PT

Applicant Careside, Inc.

K number K991065

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GJS 1998-09-30

HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT

Applicant International Technidyne Corp.

K number K972866

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GJS 1998-07-22

DADE INNOVIN

Applicant Dade Intl., Inc.

K number K974343

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GJS 1998-07-07

IL TEST PT-FIBRINOGEN RECOMBINANT

Applicant Instrumentation Laboratory CO

K number K981479

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GJS 1998-02-24

MDA SIMPLASTIN HTF

Applicant Organon Teknika Corp.

K number K974566

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GJS 1997-10-10

SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM

Applicant Sigma Diagnostics, Inc.

K number K972796

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GJS 1997-04-22

COAGUCHEK PST SYSTEM

Applicant Boehringer Mannheim Corp.

K number K962571

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GJS 1997-03-12

PROTIME MICROCOAGULATION SYSTEM

Applicant International Technidyne Corp.

K number K961835

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GJS 1996-06-28

STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS

Applicant Nova Biomedical Corp.

K number K961938

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GJS 1996-03-18

TAS PTONE

Applicant Cardiovascular Diagnostic Services

K number K955843

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GJS 1996-03-11

PROTHROMBIN TIME TEST CARD

Applicant Cardiovascular Diagnostics, Inc.

K number K954625

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GJS 1995-10-20

THROMBOPLASTIN-LI REAGENT

Applicant Helena Laboratories

K number K951820

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GJS 1995-10-06

MDA SIMPLASTIN LS

Applicant Organon Teknika Corp.

K number K952608

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GJS 1995-05-11

COAGUCHEK SYSTEM

Applicant Boehringer Mannheim Corp.

K number K942884

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GJS 1995-04-28

HEMOCHRON HNPT/FACTOR VI PT+

Applicant International Technidyne Corp.

K number K945078

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GJS 1995-04-26

ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT

Applicant Ortho Diagnostic Systems, Inc.

K number K935748

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GJS 1995-02-14

THROMBOSCREEN THROMBOPLASTIN-DS

Applicant Pacific Hemostasis

K number K940082

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GJS 1994-11-22

DADE INNOVIN II

Applicant Baxter Diagnostics, Inc.

K number K935702

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GJS 1994-05-18

MICROCOAGULATION PROTHROMBIN TIME TEST

Applicant International Technidyne Corp.

K number K940432

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GJS 1994-04-20

HELENA THROMBOPLASTIN-MI REAGENT

Applicant Helena Laboratories

K number K940310

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GJS 1994-03-30

ASSESS(TM) HIGH ABNORMAL CONTROL

Applicant Instrumentation Laboratory CO

K number K931118

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GJS 1994-03-30

ASSESS(TM) LOW ABNORMAL CONTROL

Applicant Instrumentation Laboratory CO

K number K931117

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GJS 1993-10-04

IL TEST (TM) PT-FIBRINOGEN HS PLUS

Applicant Instrumentation Laboratory CO

K number K933252

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GJS 1993-05-11

THROMBOPLATIN-M WITH CALCIUM

Applicant Sigma Diagnostics, Inc.

K number K930212

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GJS 1993-03-12

ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT

Applicant Ortho Diagnostic Systems, Inc.

K number K925604

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GJS 1993-02-12

NYCOPLASTIN

Applicant Nycomed Pharma AS

K number K920767

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GJS 1993-02-03

BIOMERIEUX HEMOLAB THROMBOMAT

Applicant Biomerieux Vitek, Inc.

K number K925492

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GJS 1992-12-07

NEOPLASTINE(R) CI KIT

Applicant American Bioproducts Co.

K number K922565

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GJS 1992-07-27

DADE RECOMBOPLASTIN S

Applicant Baxter Diagnostics, Inc.

K number K921326

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GJS 1992-06-23

NEOPLASTINE CI PLUS

Applicant American Bioproducts Co.

K number K922040

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GJS 1992-02-12

SIMPLASTIN L

Applicant Organon Teknika Corp.

K number K915746

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GJS 1991-12-04

ACS ULTRA-1 THROMBOPLASTIN

Applicant Analytical Control Systems, Inc.

K number K913249

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GJS 1991-11-27

ACS ULTRA-2 THROMBOPLASTIN

Applicant Analytical Control Systems, Inc.

K number K913250

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GJS 1991-08-09

ACS LIQUID THROMBOPLASTIN

Applicant Analytical Control Systems, Inc.

K number K912102

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GJS 1991-07-17

PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION

Applicant International Technidyne Corp.

K number K911995

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GJS 1991-04-16

HELENA THROMBOPLASTIN REAGENT WITH DILUENT

Applicant Helena Laboratories

K number K905807

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GJS 1991-02-27

HELENA THROMBOPLASTIN REAGENT, MODIFICATION

Applicant Helena Laboratories

K number K905857

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GJS 1991-01-25

COAG-1 PT-NC TEST CARD

Applicant Cardiovascular Diagnostic Services

K number K904325

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GJS 1990-12-17

HEMOCHRON(R) PROTHROMBIN TIME/MODIFICATION

Applicant International Technidyne Corp.

K number K904454

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GJS 1990-08-10

ACS ONE-STAGE PROTHROMBIN TIME REAGENT

Applicant Analytical Control Systems, Inc.

K number K902468

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GJS 1990-08-01

MODIFIED COAG-1 PT TEST CARD

Applicant Cardiovascular Diagnostic Services

K number K903019

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GJS 1990-07-03

THROMBOPLASTIN WITH CALCIUM

Applicant Sigma Chemical Co.

K number K902096

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GJS 1990-05-02

THROMBOPLASTIN.C PLUS

Applicant Baxter Healthcare Corp

K number K901325

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GJS 1989-12-11

THROMBOPLASTIN, FOR USE IN PROTHROMBIN TIME DETER.

Applicant Medical Diagnostic Technologies, Inc.

K number K896625

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GJS 1989-06-23

THROMBOSTIN IFA*

Applicant Investigacion Farmaceutica S.A. DE C.V.

K number K885107

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GJS 1989-06-22

PROTHROMBIN TIME (PT) BY HEMOCHRON

Applicant International Technidyne Corp.

K number K893378

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GJS 1989-06-07

HELENA THROMBOPLASTIN REAGENT

Applicant Helena Laboratories

K number K892050

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GJS 1989-04-21

EDL ONE-STAGE PROTHROMBIN TIME REAGENT

Applicant Elite Diagnostic , Ltd.

K number K891370

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GJS 1989-04-10

DADE THROMBOPLASTIN IS

Applicant Baxter Healthcare Corp

K number K891169

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GJS 1989-01-30

THROMBOPLASTIN

Applicant Precision Biologicals, Inc.

K number K884855

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GJS 1988-09-13

VISION(R) PROTHROMBIN TIME

Applicant Abbott Laboratories

K number K883441

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