GMH — Antiserum, Positive Control, Coccidioides Immitis Class II
FDA product code GMH covers "Antiserum, Positive Control, 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
- GMH
- 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 |
|---|---|---|---|
| K792688 | meridian diagnostics | COCCIDIOIDES IMMITIS, ANTISERUM | January 17, 1980 |
| K792684 | meridian diagnostics | COCCIDIOIDES IMMITIS, ANTISERUM, | January 17, 1980 |
| K792717 | meridian diagnostics | COCCIDIOIDES IMMITIS, ANTISERUM POS. | January 17, 1980 |
| K791388 | immuno-mycologics | ANTI-COCCIDIOIDES SERUM #CF10028X | August 16, 1979 |
| K760834 | i m | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) | November 1, 1976 |