Cleared Traditional

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO.

K900818 · Vitek Systems, Inc. · Microbiology
Apr 1990
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K900818 is an FDA 510(k) clearance for the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) TOXO., a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 30, 1990, 68 days after receiving the submission on February 21, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K900818 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1990
Decision Date April 30, 1990
Days to Decision 68 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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