Cleared Traditional

K011275 - PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY

K011275 · Psychemedics Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
Feb 2002
Decision
291d
Days
-
Risk

K011275 is an FDA 510(k) clearance for the PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Psychemedics Corp. (Culver City, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 291 days - an extended review cycle.

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.

View all Psychemedics Corp. devices

Submission Details

510(k) Number K011275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2001
Decision Date February 11, 2002
Days to Decision 291 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
204d slower than avg
Panel avg: 87d · This submission: 291d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCL Radioimmunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCL Radioimmunoassay, Phencyclidine

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