Product code GJA
- Device name
- Test, Thrombin Time
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7875
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K050817 | T-TEK | R2 Diagnostics, Inc. | 2005-12-12 |
| K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | Sigma Diagnostics, Inc. | 1998-10-15 |
| K970645 | BC THROMBIN REAGENT | Behring Diagnostics, Inc. | 1997-05-19 |
| K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | Biomerieux Vitek, Inc. | 1994-04-21 |
| K930157 | TEST THROMBIN | Behring Diagnostics, Inc. | 1993-05-14 |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | Medical Laboratory Automation Systems, Inc. | 1992-09-29 |
| K920147 | THROMBIN CLOTTING TIME REAGENT | Helena Laboratories | 1992-05-01 |
| K900126 | TT AND HNTT BY HEMOCHRON | International Technidyne Corp. | 1990-02-05 |
| K894467 | THROMBIN TIME REAGENT | Sigma Chemical Co. | 1989-09-05 |
| K884384 | THROMBIN-PREST REAGENT KIT | American Bioproducts Co. | 1988-12-28 |
| K884385 | FIBRI-PREST/THROMBIN-PREST CONTROLS | American Bioproducts Co. | 1988-12-28 |
| K862301 | IL SYSTEM 810, ACL AND THE REAGENT SETS | Instrumentation Laboratory CO | 1986-09-03 |
| K845000 | THROMBINEX BOVINE THROMBIN | Bio/Data Corp. | 1985-03-26 |
| K841956 | BOVINE THROMBIN, HUMAN THROMBIN | Haemachem, Inc. | 1984-07-19 |
| K834301 | THROMBOLYTIC ACTIVITY TEST | Bio/Data Corp. | 1984-02-04 |
| K822466 | THROMBIN TIME TEST | American Dade | 1982-09-14 |
| K811109 | THROMBIN CLOTTING TIME | Bio/Data Corp. | 1981-07-16 |
| K802117 | FIBRI QUIK | General Diagnostics | 1980-09-26 |
| K800926 | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | General Diagnostics | 1980-05-08 |
| K781781 | HEPARSORB | General Diagnostics | 1979-01-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414639635 | Test Thrombin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 10859394006054 | T-tek | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 00842768012716 | Test Thrombin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 00842768013102 | BC Thrombin Reagent | Siemens Healthcare Diagnostics Products GmbH | 2016-09-24 |
| 08426950058366 | HemosIL Thrombin Time | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 13607450006114 | STA® - Thrombin 2 | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450006695 | STA® - Thrombin 10 | DIAGNOSTICA STAGO | 2016-09-15 |
| M52553770 | Thrombin Clotting Time Reagent | HELENA LABORATORIES CORPORATION | 2016-09-07 |