JSW · Kit, Identification, Glucose Nonfermenter
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JSW |
|---|---|
| Device Name | Kit, Identification, Glucose Nonfermenter |
| 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 |
|---|---|---|---|---|
| K922768 | RAPID NFT, MODIFICATION | Biomerieux Vitek, Inc. | Oct 14, 1992 | SESE |
| K900517 | RAPID NF SYSTEM | Innovative Diagnostic Systems, Inc. | Mar 13, 1990 | SESE |
| K870769 | AUSTIN NONFERMENTER KIT | Austin Biological Laboratories | Apr 3, 1987 | SESE |
| K790992 | PSEUDO-PALETTE TM | Micro-Palettes, Inc. | Jun 22, 1979 | SESE |
| K772112 | NON-FERMENTER SYSTEM | Corning Medical & Scientific | Nov 17, 1977 | SESE |
| K770745 | PANEL, GNF, MICRO-ID | Micro-Media Systems, Inc. | Jun 23, 1977 | SESE |
Top Applicants
- Austin Biological Laboratories — 1 clearance
- Biomerieux Vitek, Inc. — 1 clearance
- Corning Medical & Scientific — 1 clearance
- Innovative Diagnostic Systems, Inc. — 1 clearance
- Micro-Media Systems, Inc. — 1 clearance
