LRH · Instrument For Auto Reader Of Overnight Microorganism Identification System
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | LRH |
|---|---|
| Device Name | Instrument For Auto Reader Of Overnight Microorganism Identification System |
| 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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962609 | GRAM NEGATIVE IDENTIFICATION PLUS CARD | Biomerieux Vitek, Inc. | Aug 30, 1996 | SESE |
| K961042 | MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL | Dade Microscan, Inc. | May 30, 1996 | SESE |
| K926248 | READER | Alamar Biosciences Laboratory, Inc. | May 17, 1994 | SESE |
| K920225 | AUTOSCEPTOR IDENTIFICATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | May 22, 1992 | SESE |
Top Applicants
- Alamar Biosciences Laboratory, Inc. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Biomerieux Vitek, Inc. — 1 clearance
- Dade Microscan, Inc. — 1 clearance
