Cleared Traditional

VIDAS ROTAVIRUS ASSAY

K965092 · Biomerieux Vitek, Inc. · Microbiology
May 1997
Decision
137d
Days
Class 1
Risk

About This 510(k) Submission

K965092 is an FDA 510(k) clearance for the VIDAS ROTAVIRUS ASSAY, a Enzyme Linked Immunoabsorbent Assay, Rotavirus (Class I — General Controls, product code LIQ), submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on May 5, 1997, 137 days after receiving the submission on December 19, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3405.

Submission Details

510(k) Number K965092 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1996
Decision Date May 05, 1997
Days to Decision 137 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIQ — Enzyme Linked Immunoabsorbent Assay, Rotavirus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3405