Cleared Traditional

THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY

K101746 · Microgenics Corp. · Chemistry
Apr 2011
Decision
290d
Days
—
Risk

About This 510(k) Submission

K101746 is an FDA 510(k) clearance for the THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY, a Enzyme Immunoassay, Phencyclidine, 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.

Submission Details

510(k) Number K101746 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 LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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