Cleared Traditional

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

K921176 · Vitek Systems, Inc. · Chemistry
Apr 1992
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K921176 is an FDA 510(k) clearance for the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM, a Radioimmunoassay, Luteinizing Hormone (Class I — General Controls, product code CEP), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 8, 1992, 28 days after receiving the submission on March 11, 1992. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1485.

Submission Details

510(k) Number K921176 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1992
Decision Date April 08, 1992
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEP — Radioimmunoassay, Luteinizing Hormone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1485

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