Cleared Traditional

DRI Benzodiazepine Assay

K173963 · Microgenics Corporation · Toxicology
Feb 2018
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K173963 is an FDA 510(k) clearance for the DRI Benzodiazepine Assay, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on February 21, 2018, 55 days after receiving the submission on December 28, 2017. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K173963 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2017
Decision Date February 21, 2018
Days to Decision 55 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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