KZB · Automated Colony Counter
Microbiology · 21 CFR 866.2170 · Class 1
Overview
| Product Code | KZB |
|---|---|
| Device Name | Automated Colony Counter |
| Regulation | 21 CFR 866.2170 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
An automated colony counter is a mechanical device intended for medical purposes to determine the number of bacterial colonies present on a bacteriological culture medium contained in a petri plate. The number of colonies counted is used in the diagnosis of disease as a measure of the degree of bacterial infection.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K893519 | TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF | Statlabs, Inc. | Aug 15, 1989 | SESE |
Top Applicants
- Statlabs, Inc. — 1 clearance
