MDE — Dna-Probe, Reagents, Cryptococcal Class II
FDA product code MDE covers "Dna-Probe, Reagents, Cryptococcal", a Class II medical device regulated under 21 CFR 866.3165. 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
- MDE
- Device Class
- Class II
- Regulation Number
- 866.3165
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K903556 | gen-probe | ACCUPROBE CRYPTOCOCCUS NEOFORMANS CULTURE TEST | October 2, 1990 |