Cleared Traditional

K900921 - HYCOR ACCUPINCH PHENCYCLIDINE TEST

K900921 · Hycor Biomedical, Inc. · Toxicology device
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Apr 1990
Decision
58d
Days
-
Risk

K900921 is an FDA 510(k) clearance for the HYCOR ACCUPINCH PHENCYCLIDINE TEST. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Hycor Biomedical, Inc. (Garden Grove, US). The FDA issued a Cleared decision on April 26, 1990 after a review of 58 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 Hycor Biomedical, Inc. devices

Submission Details

510(k) Number K900921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date April 26, 1990
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 87d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 56
Devices cleared under the same product code (LCM) and FDA review panel - the closest regulatory comparables to K900921.
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K904765 · Syva Co. · Nov 1990
MILENIA(TM) PCP
K902960 · Diagnostic Products Corp. · Aug 1990
TDX PHENCYCLIDINE II ASSAY
K900940 · Abbott Laboratories · Apr 1990
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
K895906 · Roche Diagnostic Systems, Inc. · Jan 1990
ADX TM PHENCYCLIDINE
K890688 · Abbott Laboratories · Aug 1989