Cleared Traditional

MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT

K903993 · Immunotech Corp. · Chemistry
Dec 1990
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K903993 is an FDA 510(k) clearance for the MICROZYME(TM) METHAMPHET/AMPHET ENZYME IMMUNO KIT, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on December 20, 1990, 113 days after receiving the submission on August 29, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K903993 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 1990
Decision Date December 20, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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