Cleared Traditional

K800514 - PHENCYCLIDINE DIRECT BLOOD RIA KIT

K800514 · Immunalysis Corporation · Toxicology device

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Mar 1980

Decision

14d

Days

Risk

K800514 is an FDA 510(k) clearance for the PHENCYCLIDINE DIRECT BLOOD RIA KIT. Classified as Radioimmunoassay, Phencyclidine (product code LCL).

Submitted by Immunalysis Corporation (Walker, US). The FDA issued a Cleared decision on March 19, 1980 after a review of 14 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 Immunalysis Corporation devices

Submission Details

510(k) Number	K800514 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 1980
Decision Date	March 19, 1980
Days to Decision	14 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

73d faster than avg

Panel avg: 87d · This submission: 14d

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 K800514.

REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS

K874626 · Syva Co. · Jan 1988

REVISED LABELING FOR TDX PHENCYCLIDINE

K874484 · Abbott Laboratories · Nov 1987

ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE

K830481 · Hoffmann-La Roche, Inc. · Mar 1983

ABUSCREEN RIA FOR PHENCYCLIDINE

K790655 · Hoffmann-La Roche, Inc. · Jun 1979

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K800514

Immunalysis Corporation

Walker, MI · US

Regulatory profile

50 submissions 50 cleared

100% clearance rate · Active in Toxicology

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Sourced from FDA 510(k) public files . Updated monthly.

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