TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
Device Facts
| Record ID | K893519 |
|---|---|
| Device Name | TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF |
| Applicant | Statlabs, Inc. |
| Product Code | KZB · Microbiology |
| Decision Date | Aug 15, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2170 |
| Device Class | Class 1 |
Regulatory Classification
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.
