MCS — Dna-Probe, Staphylococcus Aureus Class I
FDA product code MCS covers "Dna-Probe, Staphylococcus Aureus", a Class I medical device regulated under 21 CFR 866.3700. 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
- MCS
- Device Class
- Class I
- Regulation Number
- 866.3700
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K902213 | gen-probe | ACCUPROBE STAPHYLOCOCCUS AUREUS CULTURE CONFIRMA. | August 6, 1990 |