GMG — Antigen, Latex Agglutination, Coccidioides Immitis Class II
FDA product code GMG covers "Antigen, Latex Agglutination, Coccidioides Immitis", a Class II medical device regulated under 21 CFR 866.3135. Submissions are reviewed by the Microbiology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GMG
- 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 |
|---|---|---|---|
| K812189 | american scientific products | COCCIDIOIDES LATEX AGGLUTINATION | August 25, 1981 |
| K792690 | meridian diagnostics | COCCIDIOIDES IMMITIS, LATEX AGGLUTI | January 17, 1980 |
| K791381 | immuno-mycologics | COCCIDIODES (COCCI) | August 16, 1979 |
| K782070 | i m | REAGENT, COCCI LATEX | February 1, 1979 |
| K760829 | i m | COCCIDIOIDES MYCELIAL ANTIGEN | November 1, 1976 |