Cleared Traditional

Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

K151771 · Immunalysis Corporation · Toxicology
Jan 2016
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K151771 is an FDA 510(k) clearance for the Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on January 5, 2016, 189 days after receiving the submission on June 30, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K151771 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 2015
Decision Date January 05, 2016
Days to Decision 189 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code JXM — Enzyme Immunoassay, Benzodiazepine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3170

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