Cleared Traditional

Atellica CH Phencyclidine (Pcp)

K163220 · Siemens Healthcare Diagnostics, Inc. · Toxicology
Apr 2017
Decision
141d
Days
—
Risk

About This 510(k) Submission

K163220 is an FDA 510(k) clearance for the Atellica CH Phencyclidine (Pcp), a Enzyme Immunoassay, Phencyclidine, submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on April 6, 2017, 141 days after receiving the submission on November 16, 2016. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K163220 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2016
Decision Date April 06, 2017
Days to Decision 141 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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