Cleared Traditional

VIDAS CHLAMYDIA BLOCKING ASSAY

K955627 · Biomerieux Vitek, Inc. · Microbiology
Oct 1996
Decision
301d
Days
Class 1
Risk

About This 510(k) Submission

K955627 is an FDA 510(k) clearance for the VIDAS CHLAMYDIA BLOCKING ASSAY, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on October 7, 1996, 301 days after receiving the submission on December 11, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K955627 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1995
Decision Date October 07, 1996
Days to Decision 301 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJC — Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group)
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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