GGJ — Fluid, Diluting, White-Cell Class I
FDA product code GGJ covers "Fluid, Diluting, White-Cell", a Class I medical device regulated under 21 CFR 864.8200. 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
- GGJ
- Device Class
- Class I
- Regulation Number
- 864.8200
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K926422 | syva | VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY | June 2, 1993 |