MDC — Dna-Probe - Blastomyces Dermatitidis Class II
FDA product code MDC covers "Dna-Probe - Blastomyces Dermatitidis", a Class II medical device regulated under 21 CFR 866.3060. 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
- MDC
- Device Class
- Class II
- Regulation Number
- 866.3060
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K903201 | gen-probe | ACCUPROBE BLASTOMYCES DERMATIT CULT CONFIRM TEST | September 12, 1990 |