Cleared Traditional

MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT

K896780 · Immunotech Corp. · Toxicology
Mar 1990
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K896780 is an FDA 510(k) clearance for the MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on March 23, 1990, 109 days after receiving the submission on December 4, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K896780 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1989
Decision Date March 23, 1990
Days to Decision 109 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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