Test, Thrombin Time
The Test, Thrombin Time (product code GJA) is a hematology coagulation assay that measures the time for clot formation after addition of thrombin to plasma, assessing the conversion of fibrinogen to fibrin and used to detect fibrinogen deficiencies, dysfibrinogenemia, and the presence of heparin or thrombin inhibitors. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.7875 in the Hematology specialty (HE), it is eligible for third-party review.
Research product code GJA in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- GJA
- Device Class
- FDA class 2
- Regulation Number
- 864.7875
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K050817 | T-TEK | Dec 12, 2005 | Substantially Equivalent | R2 Diagnostics, Inc. |
| K982209 | ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 | Oct 15, 1998 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K970645 | BC THROMBIN REAGENT | May 19, 1997 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K925493 | BIOMERIEUX HEMOLAB THROMBICALCI-TEST | Apr 21, 1994 | Substantially Equivalent | Biomerieux Vitek, Inc. |
| K930157 | TEST THROMBIN | May 14, 1993 | Substantially Equivalent | Behring Diagnostics, Inc. |
| K923220 | THROMBIN CLOT TIME TEST PROCEDURE | Sep 29, 1992 | Substantially Equivalent | Medical Laboratory Automation Systems, Inc. |
| K920147 | THROMBIN CLOTTING TIME REAGENT | May 01, 1992 | Substantially Equivalent | Helena Laboratories |
| K900126 | TT AND HNTT BY HEMOCHRON | Feb 05, 1990 | Substantially Equivalent | International Technidyne Corp. |
| K894467 | THROMBIN TIME REAGENT | Sep 05, 1989 | Substantially Equivalent | Sigma Chemical Co. |
| K884385 | FIBRI-PREST/THROMBIN-PREST CONTROLS | Dec 28, 1988 | Substantially Equivalent | American Bioproducts Co. |
| K884384 | THROMBIN-PREST REAGENT KIT | Dec 28, 1988 | Substantially Equivalent | American Bioproducts Co. |
| K862301 | IL SYSTEM 810, ACL AND THE REAGENT SETS | Sep 03, 1986 | Substantially Equivalent | Instrumentation Laboratory CO |
| K845000 | THROMBINEX BOVINE THROMBIN | Mar 26, 1985 | Substantially Equivalent | Bio/Data Corp. |
| K841956 | BOVINE THROMBIN, HUMAN THROMBIN | Jul 19, 1984 | Substantially Equivalent | Haemachem, Inc. |
| K834301 | THROMBOLYTIC ACTIVITY TEST | Feb 04, 1984 | Substantially Equivalent | Bio/Data Corp. |
| K822466 | THROMBIN TIME TEST | Sep 14, 1982 | Substantially Equivalent | American Dade |
| K811109 | THROMBIN CLOTTING TIME | Jul 16, 1981 | Substantially Equivalent | Bio/Data Corp. |
| K802117 | FIBRI QUIK | Sep 26, 1980 | Substantially Equivalent | General Diagnostics |
| K800926 | THROMBOQUIK THROMBIN REAGENT PROD. #3551 | May 08, 1980 | Substantially Equivalent | General Diagnostics |
| K781781 | HEPARSORB | Jan 10, 1979 | Substantially Equivalent | General Diagnostics |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.