Cleared Traditional

Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

K152176 · Immunalysis Corporation · Toxicology
Sep 2015
Decision
31d
Days
—
Risk

About This 510(k) Submission

K152176 is an FDA 510(k) clearance for the Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators, a Enzyme Immunoassay, Phencyclidine, submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on September 4, 2015, 31 days after receiving the submission on August 4, 2015. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K152176 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2015
Decision Date September 04, 2015
Days to Decision 31 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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