GSM — Antisera, Fluorescent, Brucella Spp. Class II
FDA product code GSM covers "Antisera, Fluorescent, Brucella Spp.", a Class II medical device regulated under 21 CFR 866.3085. Submissions are reviewed by the Microbiology panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GSM
- Device Class
- Class II
- Regulation Number
- 866.3085
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K952143 | sa scientific | SAS BRUCELLA MELITENSIS ANTISERUM | July 21, 1995 |
| K952132 | sa scientific | SAS BRUCELLA AMS ANTISERUM | July 21, 1995 |
| K952146 | sa scientific | SAS BRUCELLAS ABORTUS ANTISERUM | July 21, 1995 |
| K952144 | sa scientific | SAS BRUCELLA SUIS ANTISERUM | July 21, 1995 |