Cleared Traditional

DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls

K150502 · Microgenics Corporation · Chemistry
Oct 2015
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K150502 is an FDA 510(k) clearance for the DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on October 9, 2015, 225 days after receiving the submission on February 26, 2015. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K150502 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2015
Decision Date October 09, 2015
Days to Decision 225 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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