JXC · Kit, Screening, Yeast
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JXC |
|---|---|
| Device Name | Kit, Screening, Yeast |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
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 § 866.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960075 | CHROMAGAR CANDIDA | Hardy Diagnostics | Aug 2, 1996 | SESE |
| K913426 | ALBICANS SURE | Jrga Diagnostics | Apr 22, 1992 | SESE |
| K884720 | GERM TUBE SOLUTION | Remel Co. | Jun 2, 1989 | SESE |
| K891476 | C. ALBICANS SCREEN | Carr-Scarborough Microbiologicals, Inc. | Apr 12, 1989 | SESE |
| K882371 | SOC SLIDE CULTURE SYSTEM | The Cancer Center AT Wadley Institutes | Jul 18, 1988 | SESE |
| K832406 | QUANTUM II YEAST IDENT. SYSTEM | Abbott Laboratories | Sep 26, 1983 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Carr-Scarborough Microbiologicals, Inc. — 1 clearance
- Hardy Diagnostics — 1 clearance
- Jrga Diagnostics — 1 clearance
- Remel Co. — 1 clearance
