Cleared Traditional

THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY

K101754 · Microgenics Corp. · Toxicology
Apr 2011
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K101754 is an FDA 510(k) clearance for the THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on April 8, 2011, 290 days after receiving the submission on June 22, 2010. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K101754 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2010
Decision Date April 08, 2011
Days to Decision 290 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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