GGO — Reagent, Thromboplastin And Control Class II
FDA product code GGO covers "Reagent, Thromboplastin And Control", a Class II medical device regulated under 21 CFR 864.7925. 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
- GGO
- Device Class
- Class II
- Regulation Number
- 864.7925
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K010158 | sigma diagnostics | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | March 22, 2001 |