Product code GJS
- Device name
- Test, Time, Prothrombin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7750
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253188 | CoaguChek XS Plus System | Roche Diagnostics | 2025-10-24 |
| K251564 | microINR System | Iline Microsystems, S.L. | 2025-07-21 |
| K243543 | microINR System | Iline Microsystems, S.L. | 2025-02-27 |
| K230802 | Xprecia Prime Coagulation System | Universal Biosensors Pty, Ltd. | 2024-03-15 |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Abbott Laboratories | 2023-07-14 |
| K231711 | microINR System | Iline Microsystems, S.L. | 2023-07-11 |
| K211485 | STA- NeoPTimal | Diagnostica Stago S.A.S | 2022-12-23 |
| K212779 | Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing | Coagusense, Inc. | 2022-10-05 |
| K213426 | HemosIL ReadiPlasTin | Instrumentation Laboratory CO | 2022-08-16 |
| K201185 | microINR System | Iline Microsystems, S.L. | 2020-12-18 |
| K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | Coagusense, Inc. | 2019-02-21 |
| K180780 | microINR System | Iline Microsystems, S.L. | 2019-01-25 |
| K180693 | CoaguChek XS Pro System | Roche Diagnostics | 2018-04-19 |
| K180684 | CoaguChek XS Plus System | Roche Diagnostics | 2018-04-19 |
| K170960 | CoaguChek Vantus System | Roche Diagnostics | 2017-12-25 |
| K151964 | Xprecia Stride Coagulation System, Xprecia System PT Controls | Siemens Healthcare Diagnostics | 2016-09-30 |
| K132722 | HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) | Instrumentation Laboratory CO | 2014-01-22 |
| K122584 | HEMOSIL READIPLAS TIN | Instrumentation Laboratory CO | 2013-03-24 |
| K110212 | INRATIO2 PI/NR MONITORING SYSTEM; INRATIO PT/INR TEST STRIP | Alere San Diego, Inc (Formally Biosite Incorporate | 2012-05-01 |
| K092987 | INRATIO/INRATIO2 TEST STRIPS | Biosite Incorporated | 2010-06-11 |
| K093243 | COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM | Coagusense, Inc. | 2010-04-07 |
| K093460 | COAGUCHEK XS PRO SYSTEM | Roche Diagnostics | 2010-03-18 |
| K092940 | COAGUCHEK XS PLUS PST SYSTEM | Roche Diagnostics Corp. | 2010-03-05 |
| K072920 | HANDHELD BASE UNIT | Roche Diagnostics Corp. | 2008-01-31 |
| K072727 | INRATIO 2 PT MONITORING SYSTEM | Hemosense, Inc. | 2007-10-26 |
| K070005 | HEMOSIL RECOMBIPLASTIN 2G | Instrumentation Laboratory CO | 2007-08-15 |
| K071041 | COAGUCHEK XS PLUS SYSTEM | Roche Diagnostics | 2007-05-11 |
| K062925 | COAGUCHEK XS SYSTEM | Roche Diagnostics Corp. | 2007-01-29 |
| K060978 | COAGUCHEK XS SYSTEM | Roche Diagnostics | 2006-08-11 |
| K060931 | HEMOSIL PT-FIBRINOGEN HS PLUS | Instrumentation Laboratory CO | 2006-05-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08436540291141 | microINR® Expert Kit | ILINE MICROSYSTEMS SL | 2026-04-22 |
| 09360136000079 | Xprecia Prime™ Coagulation Analyzer | UNIVERSAL BIOSENSORS PTY LTD | 2024-08-27 |
| 08436540291134 | microINR ® Link Kit | ILINE MICROSYSTEMS SL | 2024-08-02 |
| 00630414640006 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639963 | Thromborel S | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639888 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639871 | Dade Innovin | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00054749004782 | i-STAT PTplus Cartridge | Abbott Point of Care Inc. | 2024-01-10 |
| 00054749004843 | i-STAT PTplus Control Level 1 | Abbott Point of Care Inc. | 2024-01-10 |
| 00054749004850 | i-STAT PTplus Control Level2 | Abbott Point of Care Inc. | 2024-01-10 |
| 00861900000398 | Coag-Sense Test Strip Kit, 50 ct. | COAGUSENSE INC. | 2021-09-09 |
| 08436540290816 | microINR ® Meter | ILINE MICROSYSTEMS SL | 2021-05-28 |
| 08436540290717 | microINR ® CHIPS | ILINE MICROSYSTEMS SL | 2021-05-28 |
| 00630414025148 | Xprecia Stride™ Coagulation Analyzer | Siemens Healthcare Diagnostics Inc. | 2017-03-01 |
| 10859394006023 | Phosphoplastin RL | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006030 | Phosphoplastin RL | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 00627944000035 | QuikCoag PT-HS | Biomedica Diagnostics Inc | 2016-09-22 |
| 00385480347174 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480214971 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480346436 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480340816 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480322041 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480278072 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480278034 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480248198 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480243278 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480225076 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480498487 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| M52552490 | Thromboplastin-LI Reagent Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52552480 | Thromboplastin-LI Reagent Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |