Cleared Traditional

LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE (K873756) - FDA 510(k) Clearance

K873756 · Diagnostic Products Corp. · Toxicology device
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Oct 1987
Decision
41d
Days
-
Risk

K873756 is an FDA 510(k) clearance for the LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 15, 1987 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K873756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1987
Decision Date October 15, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 87d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 87
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PHENCYCLIDINE
K013096 · Abbott Laboratories · Mar 2002