MDF — Dna-Probe, Reagents, Coccidioides Immitis Class II
FDA product code MDF covers "Dna-Probe, Reagents, 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
- MDF
- 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 |
|---|---|---|---|
| K904047 | gen-probe | ACCUPROBE COCCIDIOIDES IMMITIS CULTURE CONFIRM. | October 2, 1990 |