Cleared Traditional

IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY

K131168 · Immunalysis Corporation · Toxicology
Jan 2014
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K131168 is an FDA 510(k) clearance for the IMMUNALYSIS OXYCODONE ENZYME IMMUNOASSAY, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on January 17, 2014, 268 days after receiving the submission on April 24, 2013. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K131168 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2013
Decision Date January 17, 2014
Days to Decision 268 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

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

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