GKQ — Test, Thromboplastin Generation Class I
FDA product code GKQ covers "Test, Thromboplastin Generation", a Class I medical device regulated under 21 CFR 864.7900. 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
- GKQ
- Device Class
- Class I
- Regulation Number
- 864.7900
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K823520 | bd becton dickinson vacutainer systems preanalytic | FIBROSYSTEM | December 28, 1982 |