Cleared Traditional

Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators

K161216 · Immunalysis Corporation · Toxicology
Jun 2017
Decision
411d
Days
Class 2
Risk

About This 510(k) Submission

K161216 is an FDA 510(k) clearance for the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine 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 June 14, 2017, 411 days after receiving the submission on April 29, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K161216 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2016
Decision Date June 14, 2017
Days to Decision 411 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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