GMI — Antigen, Cf And / Or Id, Coccidioides Immitis Class II
FDA product code GMI covers "Antigen, Cf And / Or Id, Coccidioides Immitis", a Class II medical device regulated under 21 CFR 866.3135. Submissions are reviewed by the Microbiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GMI
- Device Class
- Class II
- Regulation Number
- 866.3135
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K894617 | schiff and | OLYMPUS PK-TP SYSTEM REACTIVE CONTROL | October 31, 1989 |
| K812190 | american scientific products | COCCIDIOIDES IMMUNODIFFUSION SYSTEM | August 31, 1981 |
| K812185 | american scientific products | FUNGAL IMMUNODIFFUSION SYSTEM | August 25, 1981 |
| K802129 | nolan biological laboratories | IMMUNODIFFUSION REAGENTS/SEROLOGICAL | September 26, 1980 |
| K792716 | meridian diagnostics | CANDIDA ALBICANS, ANTIGEN | January 24, 1980 |
| K792713 | meridian diagnostics | CANDIDA ALBICANS, ANTISERUM | January 23, 1980 |
| K792682 | meridian diagnostics | COCCIDIOIDES IMMITIS, ANTIGEN | January 17, 1980 |
| K792689 | meridian diagnostics | COCCIDIOIDES IMMITIS, ANTIGEN | January 17, 1980 |
| K791389 | immuno-mycologics | COCCIDIOIDES ANTIGEN #CF10023X | August 16, 1979 |
| K791383 | immuno-mycologics | CANDIDA IMMUNODIFFUSION KIT #CA1001 | August 16, 1979 |
| K770527 | i m | CANDIDA IMMUNODIFFUSION KIT | March 17, 1978 |