Product Code: LCL FDA unclassified

Radioimmunoassay, Phencyclidine

Unknown

Radioimmunoassay for phencyclidine (PCP) is a laboratory test method that uses radiolabeled antibodies to detect and measure phencyclidine concentrations in patient specimens, typically for toxicology screening or drug monitoring. This device is currently unclassified by the FDA, with no assigned regulation number or medical specialty, indicating that its classification has not been finalized. The product code is LCL. No special risk flags apply.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LCL in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LCL
Device Class: FDA unclassified
Medical Specialty: Unknown
Review Panel: TX
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

Unclassified Reason

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011275	PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY	Feb 11, 2002	Substantially Equivalent	Psychemedics Corp.
K994093	AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C	Dec 16, 1999	Substantially Equivalent	Phamatech
K913864	PCP DIRECT RIA KIT (I-125)	Oct 11, 1991	Substantially Equivalent	Immunalysis Corporation
K890882	ABUSCREEN FP FOR PHENCYCLIDINE	Mar 15, 1989	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K882179	EMIT HVA PHENCYCLIDINE ASSAY	Jul 12, 1988	Substantially Equivalent	Syva Co.
K880011	REVISED LABELING FOR ADX PHENCYCLIDINE	Feb 11, 1988	Substantially Equivalent	Abbott Laboratories
K874626	REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS	Jan 11, 1988	Substantially Equivalent	Syva Co.
K874484	REVISED LABELING FOR TDX PHENCYCLIDINE	Nov 23, 1987	Substantially Equivalent	Abbott Laboratories
K830481	ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE	Mar 24, 1983	Substantially Equivalent	Hoffmann-La Roche, Inc.
K800514	PHENCYCLIDINE DIRECT BLOOD RIA KIT	Mar 19, 1980	Substantially Equivalent	Immunalysis Corporation
K790655	ABUSCREEN RIA FOR PHENCYCLIDINE	Jun 15, 1979	Substantially Equivalent	Hoffmann-La Roche, Inc.