KZB — Automated Colony Counter Class I
FDA product code KZB covers "Automated Colony Counter", a Class I medical device regulated under 21 CFR 866.2170. 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
- KZB
- Device Class
- Class I
- Regulation Number
- 866.2170
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K893519 | statlabs | TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF | August 15, 1989 |