GMA — Antisera, Fluorescent, Sporothrix Schenekii Class I
FDA product code GMA covers "Antisera, Fluorescent, Sporothrix Schenekii", a Class I medical device regulated under 21 CFR 866.3680. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- GMA
- Device Class
- Class I
- Regulation Number
- 866.3680
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K802427 | immuno-mycologics | LA-SPORO ANTIBODY SYSTEM | October 31, 1980 |