Test, Thrombin Time
FDA product code GJA · Class II (moderate risk) · 21 CFR 864.7875 · Hematology
20510(k) clearances
0PMA approvals
1recalls
Manufacturers
- General Diagnostics 3
- Bio/Data Corp. 3
- American Bioproducts Co. 2
- Behring Diagnostics, Inc. 2
- American Dade 1
- Haemachem, Inc. 1
- Instrumentation Laboratory CO 1
- Sigma Chemical Co. 1
- International Technidyne Corp. 1
- Helena Laboratories 1
- Medical Laboratory Automation Systems, Inc. 1
- Biomerieux Vitek, Inc. 1
- Sigma Diagnostics, Inc. 1
- R2 Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050817 | T-TekGJA · Traditional | R2 Diagnostics, Inc. | 12/12/2005SE |
| K982209 | Accuclot Thrombin Time Reagent Model A8713/A4589GJA · Traditional | Sigma Diagnostics, Inc. | 10/15/1998SE |
| K970645 | BC Thrombin ReagentGJA · Traditional | Behring Diagnostics, Inc. | 05/19/1997SE |
| K925493 | Biomerieux Hemolab Thrombicalci-TestGJA · Traditional | Biomerieux Vitek, Inc. | 04/21/1994SE |
| K930157 | Test ThrombinGJA · Traditional | Behring Diagnostics, Inc. | 05/14/1993SE |
| K923220 | Thrombin Clot Time Test ProcedureGJA · Traditional | Medical Laboratory Automation Systems, Inc. | 09/29/1992SE |
| K920147 | Thrombin Clotting Time ReagentGJA · Traditional | Helena Laboratories | 05/01/1992SE |
| K900126 | TT and HNTT by HemochronGJA · Traditional | International Technidyne Corp. | 02/05/1990SE |
| K894467 | Thrombin Time ReagentGJA · Traditional | Sigma Chemical Co. | 09/05/1989SE |
| K884385 | Fibri-Prest/Thrombin-Prest ControlsGJA · Traditional | American Bioproducts Co. | 12/28/1988SE |
| K884384 | Thrombin-Prest Reagent KitGJA · Traditional | American Bioproducts Co. | 12/28/1988SE |
| K862301 | Il System 810, Acl and the Reagent SetsGJA · Traditional | Instrumentation Laboratory CO | 09/03/1986SE |
| K845000 | Thrombinex Bovine ThrombinGJA · Traditional | Bio/Data Corp. | 03/26/1985SE |
| K841956 | Bovine Thrombin, Human ThrombinGJA · Traditional | Haemachem, Inc. | 07/19/1984SE |
| K834301 | Thrombolytic Activity TestGJA · Traditional | Bio/Data Corp. | 02/04/1984SE |
| K822466 | Thrombin Time TestGJA · Traditional | American Dade | 09/14/1982SE |
| K811109 | Thrombin Clotting TimeGJA · Traditional | Bio/Data Corp. | 07/16/1981SE |
| K802117 | Fibri QuikGJA · Traditional | General Diagnostics | 09/26/1980SE |
| K800926 | Thromboquik Thrombin Reagent Prod. #3551GJA · Traditional | General Diagnostics | 05/08/1980SE |
| K781781 | HeparsorbGJA · Traditional | General Diagnostics | 01/10/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0827-2018 Class II | BC Thrombin Reagent Kit Lot Number 46751; UDI - 008427680131024675120180908 and BC…The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains… | Siemens Healthcare Diagnostics | 10/17/2017Terminated |