GJB — Thrombin Class II
FDA product code GJB covers "Thrombin", a Class II medical device regulated under 21 CFR 864.7875. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- GJB
- Device Class
- Class II
- Regulation Number
- 864.7875
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K820084 | american dade | CLOTTING TIME REAGENT | February 22, 1982 |