Cleared Traditional

USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400

K935629 · U.S. Drug Testing, Inc. · Toxicology
Apr 1994
Decision
140d
Days
—
Risk

About This 510(k) Submission

K935629 is an FDA 510(k) clearance for the USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400, a Enzyme Immunoassay, Phencyclidine, submitted by U.S. Drug Testing, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on April 12, 1994, 140 days after receiving the submission on November 23, 1993. This device falls under the Toxicology review panel.

Submission Details

510(k) Number K935629 FDA.gov
FDA Decision Cleared SESE
Date Received November 23, 1993
Decision Date April 12, 1994
Days to Decision 140 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LCM — Enzyme Immunoassay, Phencyclidine
Device Class —

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