Cleared Traditional

K874484 - REVISED LABELING FOR TDX PHENCYCLIDINE

K874484 · Abbott Laboratories · Toxicology device
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Nov 1987
Decision
24d
Days
-
Risk

K874484 is an FDA 510(k) clearance for the REVISED LABELING FOR TDX PHENCYCLIDINE. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 23, 1987 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.

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FDA 510(k) Submission Details - K874484

510(k) Number K874484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1987
Decision Date November 23, 1987
Days to Decision 24 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
63d faster than avg
Panel avg: 87d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

LCL Device Classification - Class 0,

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 K874484.
EMIT HVA PHENCYCLIDINE ASSAY
K882179 · Syva Co. · Jul 1988
REVISED LABELING FOR ADX PHENCYCLIDINE
K880011 · Abbott Laboratories · Feb 1988
REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS
K874626 · Syva Co. · Jan 1988
ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
K830481 · Hoffmann-La Roche, Inc. · Mar 1983
PHENCYCLIDINE DIRECT BLOOD RIA KIT
K800514 · Immunalysis Corporation · Mar 1980
ABUSCREEN RIA FOR PHENCYCLIDINE
K790655 · Hoffmann-La Roche, Inc. · Jun 1979