GSO
12 FDA 510(k) clearances · Product code
70 daysmedian time to decision
71 days90th percentile
12clearances measured
FDA profile
- Official device name
- Antigens (Febrile), Agglutination, Brucella Spp.
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3085
- Medical specialty
- Microbiology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VISTA ANTIGEN BRUCELLA ABORTUS (K972394) | Lee Laboratories, Inc. | 1997-08-25 |
| VISTA ANTIGEN BRUCELLA MELITENSIS (K972396) | Lee Laboratories, Inc. | 1997-08-25 |
| SAS BRUCELLA SUIS ANTIGEN (K952139) | Sa Scientific, Inc. | 1995-07-18 |
| SAS SALMONELLA H A ANTIGEN (K952137) | Sa Scientific, Inc. | 1995-07-17 |
| SAS FEBRILE ANTIGEN SET (K952131) | Sa Scientific, Inc. | 1995-07-17 |
| SAS BRUCELLA MELTIENSIS ANTIGEN (K952140) | Sa Scientific, Inc. | 1995-07-17 |
| SAS BRUCELLA ABORTUS ANTIGEN (K952147) | Sa Scientific, Inc. | 1995-07-17 |
| SAS SALMONELLA H B ANTIGEN (K952136) | Sa Scientific, Inc. | 1995-07-17 |
| SAS SALMONELLA H D ANTIGEN (K952135) | Sa Scientific, Inc. | 1995-07-17 |
| BRUCELLA IFA* (K885112) | Investigacion Farmaceutica S.A. DE C.V. | 1989-08-15 |
| FEBRILE ANTIGEN KIT (K822663) | Oxoid U.S.A., Inc. | 1982-09-21 |
| AGGLUTINOTEST-BRUCELLA (K791449) | Volu Sol Medical Industries | 1979-09-24 |
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Every clearance here is in the API, with alerts when new ones post.