Cleared Traditional

PHENCYCLIDINE EIA ASSAY (K915179) - FDA 510(k) Clearance

K915179 · Diagnostic Reagents, Inc. · Toxicology device
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Dec 1991
Decision
24d
Days
-
Risk

K915179 is an FDA 510(k) clearance for the PHENCYCLIDINE EIA ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Diagnostic Reagents, Inc. (Santa Clara, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 24 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 Reagents, Inc. devices

Submission Details

510(k) Number K915179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1991
Decision Date December 09, 1991
Days to Decision 24 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
63d faster than avg
Panel avg: 87d · This submission: 24d
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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