MCT — Dna-Probe, Strep Pneumoniae Class I
FDA product code MCT covers "Dna-Probe, Strep Pneumoniae", a Class I medical device regulated under 21 CFR 866.3740. 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
- MCT
- Device Class
- Class I
- Regulation Number
- 866.3740
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K902908 | gen-probe | ACCUPROBE STREPTOCOCCUS PNEUMONIAE CULTURE CONFIR. | August 6, 1990 |