KZK · Reader, Zone, Automated
Microbiology · 21 CFR 866.2850 · Class 1
Overview
| Product Code | KZK |
|---|---|
| Device Name | Reader, Zone, Automated |
| Regulation | 21 CFR 866.2850 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class I (general controls).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991473 | SIRSCAN | Intelligence Artificielle Applications | Nov 23, 1999 | SESE |
| K944319 | BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM | Giles Scientific, Inc. | Dec 15, 1994 | SESE |
| K932122 | BIOMIC VIDEO PLATE READER | Giles Scientific, Inc. | Mar 1, 1994 | SESE |
Top Applicants
- Giles Scientific, Inc. — 2 clearances
- Intelligence Artificielle Applications — 1 clearance
