Cleared Traditional

USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400 (K935629) - FDA 510(k) Clearance

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

K935629 is an FDA 510(k) clearance for the USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by U.S. Drug Testing, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on April 12, 1994 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K935629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 87d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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