Cleared Traditional

PSYCHEMEDICS PHENCYCLIDINE EIA

K111928 · Psychemedics Corp. · Chemistry
May 2012
Decision
300d
Days
—
Risk

About This 510(k) Submission

K111928 is an FDA 510(k) clearance for the PSYCHEMEDICS PHENCYCLIDINE EIA, a Enzyme Immunoassay, Phencyclidine, submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on May 1, 2012, 300 days after receiving the submission on July 6, 2011. This device falls under the Chemistry review panel.

Submission Details

510(k) Number K111928 FDA.gov
FDA Decision Cleared SESE
Date Received July 06, 2011
Decision Date May 01, 2012
Days to Decision 300 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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