Thrombin Clotting Time
510(k) K811109
Thrombin Clotting Time is a Class II device made by Bio/Data Corp., cleared under FDA 510(k) K811109 on 16 Jul 1981, active as of 9 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811109 | Date16 Jul 1981 | StatusActive |
Official records
- FDA 510(k) database K811109
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GJA
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7875
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
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Other devices filed under FDA product code GJA (Test, Thrombin Time).
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- IL System 810 ACL and Reagent Sets by INSTRUMENTATION LABORATORY COMPANY
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- TT AND HNTT BY HEMOCHRON by International Technidyne Corp.