BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM
Device Facts
| Record ID | K944319 |
|---|---|
| Device Name | BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM |
| Applicant | Giles Scientific, Inc. |
| Product Code | KZK · Microbiology |
| Decision Date | Dec 15, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.2850 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An automated zone reader is a mechanical device intended for medical purposes to measure zone diameters of microbial growth inhibition (or exhibition), such as those observed on the surface of certain culture media used in disc-agar diffusion antimicrobial susceptibility tests. The device aids in decisionmaking respecting the treatment of disease.
