Cleared Traditional

K864244 - GARNERELLA VAGINALIS IDENTIFICATION KIT
(FDA 510(k) Clearance)

K864244 · Mds Laboratories, Inc. · Microbiology device

Mar 1987

Decision

154d

Days

Class 1

Risk

K864244 is an FDA 510(k) clearance for the GARNERELLA VAGINALIS IDENTIFICATION KIT. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I - General Controls, product code JTO).

Submitted by Mds Laboratories, Inc. (L5j 2m4, CA). The FDA issued a Cleared decision on March 31, 1987, 154 days after receiving the submission on October 28, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K864244 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 28, 1986
Decision Date	March 31, 1987
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—