FDA Product Code
FDA Product Code GJA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7875
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K050817 | T-TEK | R2 Diagnostics, Inc. | 2005-12-12 | Traditional | PDF ↗ |
| K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | Sigma Diagnostics, Inc. | 1998-10-15 | Traditional | PDF ↗ |
| K970645 | BC THROMBIN REAGENT | Behring Diagnostics, Inc. | 1997-05-19 | Traditional | PDF ↗ |
| K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | Biomerieux Vitek, Inc. | 1994-04-21 | Traditional | PDF ↗ |
| K930157 | TEST THROMBIN | Behring Diagnostics, Inc. | 1993-05-14 | Traditional | PDF ↗ |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | Medical Laboratory Automation Systems, Inc. | 1992-09-29 | Traditional | PDF ↗ |
| K920147 | THROMBIN CLOTTING TIME REAGENT | Helena Laboratories | 1992-05-01 | Traditional | PDF ↗ |
| K900126 | TT AND HNTT BY HEMOCHRON | International Technidyne Corp. | 1990-02-05 | Traditional | PDF ↗ |
| K894467 | THROMBIN TIME REAGENT | Sigma Chemical Co. | 1989-09-05 | Traditional | PDF ↗ |
| K884385 | FIBRI-PREST/THROMBIN-PREST CONTROLS | American Bioproducts Co. | 1988-12-28 | Traditional | PDF ↗ |
| K884384 | THROMBIN-PREST REAGENT KIT | American Bioproducts Co. | 1988-12-28 | Traditional | PDF ↗ |
| K862301 | IL SYSTEM 810, ACL AND THE REAGENT SETS | Instrumentation Laboratory CO | 1986-09-03 | Traditional | PDF ↗ |
| K845000 | THROMBINEX BOVINE THROMBIN | Bio/Data Corp. | 1985-03-26 | Traditional | PDF ↗ |
| K841956 | BOVINE THROMBIN, HUMAN THROMBIN | Haemachem, Inc. | 1984-07-19 | Traditional | PDF ↗ |
| K834301 | THROMBOLYTIC ACTIVITY TEST | Bio/Data Corp. | 1984-02-04 | Traditional | PDF ↗ |
| K822466 | THROMBIN TIME TEST | American Dade | 1982-09-14 | Traditional | PDF ↗ |
| K811109 | THROMBIN CLOTTING TIME | Bio/Data Corp. | 1981-07-16 | Traditional | PDF ↗ |
| K802117 | FIBRI QUIK | General Diagnostics | 1980-09-26 | Traditional | PDF ↗ |
| K800926 | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | General Diagnostics | 1980-05-08 | Traditional | PDF ↗ |
| K781781 | HEPARSORB | General Diagnostics | 1979-01-10 | Traditional | PDF ↗ |
Product code GJA · Class II · Hematology. Data: openFDA.