Cleared Traditional

K874626 - REVISED LABELING FOR SYVA PHENCYCLIDINE...

K874626 · Syva Co. · Toxicology device
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Jan 1988
Decision
62d
Days
-
Risk

K874626 is an FDA 510(k) clearance for the REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on January 11, 1988 after a review of 62 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 Syva Co. devices

Submission Details

510(k) Number K874626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1987
Decision Date January 11, 1988
Days to Decision 62 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
25d faster than avg
Panel avg: 87d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCL Radioimmunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCL Radioimmunoassay, Phencyclidine

All 9
Devices cleared under the same product code (LCL) and FDA review panel - the closest regulatory comparables to K874626.
ABUSCREEN FP FOR PHENCYCLIDINE
K890882 · Roche Diagnostic Systems, Inc. · Mar 1989
EMIT HVA PHENCYCLIDINE ASSAY
K882179 · Syva Co. · Jul 1988
REVISED LABELING FOR ADX PHENCYCLIDINE
K880011 · Abbott Laboratories · Feb 1988
REVISED LABELING FOR TDX PHENCYCLIDINE
K874484 · Abbott Laboratories · Nov 1987
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
K830481 · Hoffmann-La Roche, Inc. · Mar 1983
PHENCYCLIDINE DIRECT BLOOD RIA KIT
K800514 · Immunalysis Corporation · Mar 1980