Cleared Traditional

CEDIA Benzodiazepine Assay

K190968 · Microgenics Corporation · Toxicology
Dec 2019
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K190968 is an FDA 510(k) clearance for the CEDIA Benzodiazepine Assay, a Enzyme Immunoassay, Benzodiazepine (Class II — Special Controls, product code JXM), submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on December 9, 2019, 241 days after receiving the submission on April 12, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3170.

Submission Details

510(k) Number K190968 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2019
Decision Date December 09, 2019
Days to Decision 241 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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