Cleared Traditional

CEDIA Heroin Metabolite (6-AM) assay

K192943 · Microgenics Corporation · Toxicology
Dec 2019
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K192943 is an FDA 510(k) clearance for the CEDIA Heroin Metabolite (6-AM) assay, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on December 16, 2019, 59 days after receiving the submission on October 18, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K192943 FDA.gov
FDA Decision Cleared SESE
Date Received October 18, 2019
Decision Date December 16, 2019
Days to Decision 59 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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