510(k) K830481

Device: ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE
Applicant: HOFFMANN-LA ROCHE, INC.
510(k) number: K830481
Product code: LCL
Decision: Substantially Equivalent (SESE)
Decision date: 1983-03-24
Date received: 1983-02-15
Regulation: 510(k) Premarket Notification
Classification name: Radioimmunoassay, Phencyclidine
Medical specialty: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Review panel: Toxicology
Device class: U
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

1832216

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LCL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K011275	PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY	Psychemedics Corp.	2002-02-11
K994093	AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C	Phamatech	1999-12-16
K913864	PCP DIRECT RIA KIT (I-125)	Immunalysis Corporation	1991-10-11
K890882	ABUSCREEN FP FOR PHENCYCLIDINE	Roche Diagnostic Systems, Inc.	1989-03-15
K882179	EMIT HVA PHENCYCLIDINE ASSAY	Syva Co.	1988-07-12
K880011	REVISED LABELING FOR ADX PHENCYCLIDINE	Abbott Laboratories	1988-02-11
K874626	REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS	Syva Co.	1988-01-11
K874484	REVISED LABELING FOR TDX PHENCYCLIDINE	Abbott Laboratories	1987-11-23
K800514	PHENCYCLIDINE DIRECT BLOOD RIA KIT	Immunalysis Corporation	1980-03-19
K790655	ABUSCREEN RIA FOR PHENCYCLIDINE	Hoffmann-La Roche, Inc.	1979-06-15

Legacy Summary#

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