Cleared Traditional

THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY

K101745 · Microgenics Corp. · Chemistry
Apr 2011
Decision
290d
Days
Class 2
Risk

About This 510(k) Submission

K101745 is an FDA 510(k) clearance for the THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), 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 Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K101745 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 Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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