Cleared Traditional

VITEK YEAST BIOCHEMICAL CARD

K881925 · Vitek Systems, Inc. · Microbiology
Jun 1988
Decision
38d
Days
Class 1
Risk

About This 510(k) Submission

K881925 is an FDA 510(k) clearance for the VITEK YEAST BIOCHEMICAL CARD, a Kit, Identification, Yeast (Class I — General Controls, product code JXB), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on June 16, 1988, 38 days after receiving the submission on May 9, 1988. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K881925 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1988
Decision Date June 16, 1988
Days to Decision 38 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JXB — Kit, Identification, Yeast
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660