Cleared Traditional

MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT

K902194 · Immunotech Corp. · Toxicology
Jul 1990
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K902194 is an FDA 510(k) clearance for the MICRO DAU OPIATE ENZYME IMMUNOASSAY KIT, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on July 17, 1990, 62 days after receiving the submission on May 16, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K902194 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1990
Decision Date July 17, 1990
Days to Decision 62 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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