LIB · Device, General Purpose, Microbiology, Diagnostic
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | LIB |
|---|---|
| Device Name | Device, General Purpose, Microbiology, Diagnostic |
| 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 (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K023677 | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) | Osmetech | Jan 29, 2003 | SESE |
| K920416 | SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB | Behring Diagnostics, Inc. | Apr 8, 1992 | SESE |
| K912558 | GULL ELISAWARE | Gull Laboratories, Inc. | Sep 16, 1991 | SESE |
| K872273 | CORNING EASY WASH ELISA PLATES | Corning Medical & Scientific | Jul 7, 1987 | SESE |
| K871559 | CELL LIFTER | Corning Costar Corp. | May 15, 1987 | SESE |
| K864249 | NORMAL SALINE STERILE | Mds Laboratories, Inc. | Mar 31, 1987 | SESE |
| K863789 | CORNING ELISA PLATES | Corning Medical & Scientific | Oct 3, 1986 | SESE |
| K862112 | MICROSCOPE SLIDES | Abco Dealers, Inc. | Jun 13, 1986 | SESE |
| K854604 | AUTO MASH | Dynatech Corp. | Dec 6, 1985 | SESE |
| K854603 | MULTI MASH 2000 | Dynatech Corp. | Dec 6, 1985 | SESE |
| K854602 | MINI MASH 2000 | Dynatech Corp. | Dec 6, 1985 | SESE |
| K854423 | IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES | Dynatech Laboratories, Inc. | Nov 20, 1985 | SESE |
| K853285 | MYWASHER 5 | Scientific Sales Intl., Inc. | Oct 4, 1985 | SESE |
| K853745 | MIC-CONCEPT VIEWBOX | Microtech Medical Systems, Inc. | Sep 19, 1985 | SESE |
| K850725 | QUADRA TITER MICRO PLATES | Microtech Medical Systems, Inc. | Apr 30, 1985 | SESE |
| K844476 | PORTABLE DIAGNOSTIC LABORATORY | Portable Medical Laboratories, Inc. | Mar 13, 1985 | SESE |
| K844442 | RAPID DIAGNOSTIC KIT | Portable Medical Laboratories, Inc. | Feb 1, 1985 | SESE |
| K844473 | HAND-HELD SLIDE READER | Portable Medical Laboratories, Inc. | Jan 4, 1985 | SESE |
| K843483 | PHARMA-PLAST PETRI DISH | Zimmar Consulting , Ltd. | Sep 21, 1984 | SESE |
| K842052 | GIARDIA GUARD | Gelman Sciences, Inc. | Sep 11, 1984 | SESE |
Top Applicants
- Dynatech Corp. — 10 clearances
- Organon Teknika Corp. — 4 clearances
- Corning Medical & Scientific — 3 clearances
- Plastic Injectors, Inc. — 3 clearances
- Portable Medical Laboratories, Inc. — 3 clearances
