Cleared Traditional

VIDAS CHLAMYDIA ASSAY, MODIFICATION

K915884 · Vitek Systems, Inc. · Microbiology
Mar 1992
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K915884 is an FDA 510(k) clearance for the VIDAS CHLAMYDIA ASSAY, MODIFICATION, a Enzyme Linked Immunoabsorbent Assay, (chlamydiae Group) (Class I — General Controls, product code LJC), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on March 4, 1992, 83 days after receiving the submission on December 12, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K915884 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1991
Decision Date March 04, 1992
Days to Decision 83 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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