Cleared Traditional

THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY

K093114 · Microgenics Corp. · Chemistry
May 2010
Decision
223d
Days
Class 2
Risk

About This 510(k) Submission

K093114 is an FDA 510(k) clearance for the THERMO SCIENTIFIC DRI AMPHETAMINES 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 May 12, 2010, 223 days after receiving the submission on October 1, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K093114 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2009
Decision Date May 12, 2010
Days to Decision 223 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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