Cleared Traditional

K935320 - PHENCYCLIDINE EIA ASSAY

K935320 · Diagnostic Reagents, Inc. · Toxicology device
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Dec 1993
Decision
76d
Days
-
Risk

K935320 is an FDA 510(k) clearance for the PHENCYCLIDINE EIA ASSAY. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on December 29, 1993 after a review of 76 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 K935320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1993
Decision Date December 29, 1993
Days to Decision 76 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 87d · This submission: 76d
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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