Panels › Hematology › Product code GJA · Class 2
Test, Thrombin Time
Regulation 864.7875
0510(k)s in 12 months (20 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in GJA
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio/Data Corp. | 3 | 0 |
| General Diagnostics | 3 | 0 |
| American Bioproducts Co. | 2 | 0 |
| Behring Diagnostics, Inc. | 2 | 0 |
| bioMerieux | 0 | 2 |
| American Dade | 1 | 0 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Dade Behring , Inc. | 0 | 1 |
| Haemachem, Inc. | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 2005 | K050817 | T-TEK R2 Diagnostics, Inc. | GJA |
| Oct 15, 1998 | K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 Sigma Diagnostics, Inc. | GJA |
| May 19, 1997 | K970645 | BC THROMBIN REAGENT Behring Diagnostics, Inc. | GJA |
| Apr 21, 1994 | K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST Biomerieux Vitek, Inc. | GJA |
| May 14, 1993 | K930157 | TEST THROMBIN Behring Diagnostics, Inc. | GJA |
| Sep 29, 1992 | K923220 | THROMBIN CLOT TIME TEST PROCEDURE Medical Laboratory Automation Systems, Inc. | GJA |
| May 1, 1992 | K920147 | THROMBIN CLOTTING TIME REAGENT Helena Laboratories | GJA |
| Feb 5, 1990 | K900126 | TT AND HNTT BY HEMOCHRON International Technidyne Corp. | GJA |
| Sep 5, 1989 | K894467 | THROMBIN TIME REAGENT Sigma Chemical Co. | GJA |
| Dec 28, 1988 | K884385 | FIBRI-PREST/THROMBIN-PREST CONTROLS American Bioproducts Co. | GJA |
| Dec 28, 1988 | K884384 | THROMBIN-PREST REAGENT KIT American Bioproducts Co. | GJA |
| Sep 3, 1986 | K862301 | IL SYSTEM 810, ACL AND THE REAGENT SETS Instrumentation Laboratory CO | GJA |
| Mar 26, 1985 | K845000 | THROMBINEX BOVINE THROMBIN Bio/Data Corp. | GJA |
| Jul 19, 1984 | K841956 | BOVINE THROMBIN, HUMAN THROMBIN Haemachem, Inc. | GJA |
| Feb 4, 1984 | K834301 | THROMBOLYTIC ACTIVITY TEST Bio/Data Corp. | GJA |
| Sep 14, 1982 | K822466 | THROMBIN TIME TEST American Dade | GJA |
| Jul 16, 1981 | K811109 | THROMBIN CLOTTING TIME Bio/Data Corp. | GJA |
| Sep 26, 1980 | K802117 | FIBRI QUIK General Diagnostics | GJA |
| May 8, 1980 | K800926 | THROMBOQUIK THROMBIN REAGENT PROD. #3551 General Diagnostics | GJA |
| Jan 10, 1979 | K781781 | HEPARSORB General Diagnostics | GJA |
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