GSO — Antigens (Febrile), Agglutination, Brucella Spp. Class II
FDA product code GSO covers "Antigens (Febrile), Agglutination, Brucella Spp.", a Class II medical device regulated under 21 CFR 866.3085. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GSO
- 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 |
|---|---|---|---|
| K972396 | lee laboratories | VISTA ANTIGEN BRUCELLA MELITENSIS | August 25, 1997 |
| K972394 | lee laboratories | VISTA ANTIGEN BRUCELLA ABORTUS | August 25, 1997 |
| K952139 | sa scientific | SAS BRUCELLA SUIS ANTIGEN | July 18, 1995 |
| K952147 | sa scientific | SAS BRUCELLA ABORTUS ANTIGEN | July 17, 1995 |
| K952136 | sa scientific | SAS SALMONELLA H B ANTIGEN | July 17, 1995 |
| K952135 | sa scientific | SAS SALMONELLA H D ANTIGEN | July 17, 1995 |
| K952140 | sa scientific | SAS BRUCELLA MELTIENSIS ANTIGEN | July 17, 1995 |
| K952137 | sa scientific | SAS SALMONELLA H A ANTIGEN | July 17, 1995 |
| K952131 | sa scientific | SAS FEBRILE ANTIGEN SET | July 17, 1995 |
| K885112 | investigacion farmaceutica s.a. de c.v | BRUCELLA IFA* | August 15, 1989 |
| K822663 | oxoid u.s.a | FEBRILE ANTIGEN KIT | September 21, 1982 |
| K791449 | volu sol medical industries | AGGLUTINOTEST-BRUCELLA | September 24, 1979 |