MIY — Enzyme Linked Immunosorbent Assay, Coccidioides Immitis Class II
FDA product code MIY covers "Enzyme Linked Immunosorbent Assay, Coccidioides Immitis", a Class II medical device regulated under 21 CFR 866.3135. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- MIY
- 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 |
|---|---|---|---|
| K915493 | meridian diagnostics | PREMIER COCCIDIOIDES | July 10, 1992 |