Cleared Traditional

DRI Hydrocodone Assay

K173195 · Microgenics Corporation · Toxicology
Feb 2018
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K173195 is an FDA 510(k) clearance for the DRI Hydrocodone 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 February 13, 2018, 134 days after receiving the submission on October 2, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K173195 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2017
Decision Date February 13, 2018
Days to Decision 134 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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