Cleared Traditional

Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set

K143500 · Immunalysis Corporation · Toxicology
Feb 2015
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K143500 is an FDA 510(k) clearance for the Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on February 6, 2015, 58 days after receiving the submission on December 10, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K143500 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2014
Decision Date February 06, 2015
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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