Cleared Traditional

Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

K153693 · Immunalysis Corporation · Toxicology
Mar 2016
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K153693 is an FDA 510(k) clearance for the Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators, a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on March 18, 2016, 86 days after receiving the submission on December 23, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K153693 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 2015
Decision Date March 18, 2016
Days to Decision 86 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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