Cleared Traditional

RAPID NFT, MODIFICATION

K922768 · Biomerieux Vitek, Inc. · Microbiology

Oct 1992

Decision

128d

Days

Class 1

Risk

About This 510(k) Submission

K922768 is an FDA 510(k) clearance for the RAPID NFT, MODIFICATION, a Kit, Identification, Glucose Nonfermenter (Class I — General Controls, product code JSW), submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 14, 1992, 128 days after receiving the submission on June 8, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K922768 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 1992
Decision Date	October 14, 1992
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF