GJA · Test, Thrombin Time
Hematology · 21 CFR 864.7875 · Class 2
Overview
| Product Code | GJA |
|---|---|
| Device Name | Test, Thrombin Time |
| Regulation | 21 CFR 864.7875 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K050817 | T-TEK | R2 Diagnostics, Inc. | Dec 12, 2005 | SESE |
| K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | Sigma Diagnostics, Inc. | Oct 15, 1998 | SESE |
| K970645 | BC THROMBIN REAGENT | Behring Diagnostics, Inc. | May 19, 1997 | SESE |
| K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | Biomerieux Vitek, Inc. | Apr 21, 1994 | SESE |
| K930157 | TEST THROMBIN | Behring Diagnostics, Inc. | May 14, 1993 | SESE |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | Medical Laboratory Automation Systems, Inc. | Sep 29, 1992 | SESE |
| K920147 | THROMBIN CLOTTING TIME REAGENT | Helena Laboratories | May 1, 1992 | SESE |
| K900126 | TT AND HNTT BY HEMOCHRON | International Technidyne Corp. | Feb 5, 1990 | SESE |
| K894467 | THROMBIN TIME REAGENT | Sigma Chemical Co. | Sep 5, 1989 | SESE |
| K884385 | FIBRI-PREST/THROMBIN-PREST CONTROLS | American Bioproducts Co. | Dec 28, 1988 | SESE |
| K884384 | THROMBIN-PREST REAGENT KIT | American Bioproducts Co. | Dec 28, 1988 | SESE |
| K862301 | IL SYSTEM 810, ACL AND THE REAGENT SETS | Instrumentation Laboratory CO | Sep 3, 1986 | SESE |
| K845000 | THROMBINEX BOVINE THROMBIN | Bio/Data Corp. | Mar 26, 1985 | SESE |
| K841956 | BOVINE THROMBIN, HUMAN THROMBIN | Haemachem, Inc. | Jul 19, 1984 | SESE |
| K834301 | THROMBOLYTIC ACTIVITY TEST | Bio/Data Corp. | Feb 4, 1984 | SESE |
| K822466 | THROMBIN TIME TEST | American Dade | Sep 14, 1982 | SESE |
| K811109 | THROMBIN CLOTTING TIME | Bio/Data Corp. | Jul 16, 1981 | SESE |
| K802117 | FIBRI QUIK | General Diagnostics | Sep 26, 1980 | SESE |
| K800926 | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | General Diagnostics | May 8, 1980 | SESE |
| K781781 | HEPARSORB | General Diagnostics | Jan 10, 1979 | SESE |
Top Applicants
- Bio/Data Corp. — 3 clearances
- General Diagnostics — 3 clearances
- American Bioproducts Co. — 2 clearances
- Behring Diagnostics, Inc. — 2 clearances
- American Dade — 1 clearance
