Cleared Traditional

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

K161714 · Immunalysis Corporation · Toxicology
Oct 2016
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K161714 is an FDA 510(k) clearance for the Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on October 14, 2016, 115 days after receiving the submission on June 21, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K161714 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2016
Decision Date October 14, 2016
Days to Decision 115 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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