Cleared Traditional

IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS

K141406 · Immunalysis Corporation · Toxicology
Jul 2014
Decision
34d
Days
Class 2
Risk

About This 510(k) Submission

K141406 is an FDA 510(k) clearance for the IMMUNALYSIS BUPRENORPHINE URINE ENZYME IMMUNOASSAY, IMMUNALYSIS BUPRENORPHINE URINE CONTROLS AND CALIBRATORS, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on July 1, 2014, 34 days after receiving the submission on May 28, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K141406 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2014
Decision Date July 01, 2014
Days to Decision 34 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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