GSM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antisera, Fluorescent, Brucella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3085
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1997: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SAS BRUCELLAS ABORTUS ANTISERUM (K952146) | Sa Scientific, Inc. | 1995-07-21 |
| SAS BRUCELLA SUIS ANTISERUM (K952144) | Sa Scientific, Inc. | 1995-07-21 |
| SAS BRUCELLA MELITENSIS ANTISERUM (K952143) | Sa Scientific, Inc. | 1995-07-21 |
| SAS BRUCELLA AMS ANTISERUM (K952132) | Sa Scientific, Inc. | 1995-07-21 |
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