Roche Diagnostic Systems, Inc.

FDA 510(k) & PMA Approved Devices — 296 products

Total Devices296

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K983698	MODIFICATION TO ABUSCREEN ONLINE BARBITURATES	DIS	1999-05-03	View
510(k)	K983702	MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES	JXM	1999-02-11	View
510(k)	K983704	MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE	JCM	1999-02-10	View
510(k)	K983555	ABUSCREEN ONLINE BENZ 200 CALIBRATORS	DLJ	1998-12-15	View
510(k)	K983556	ABUSCREEN ONLINE BENZ 300 CALIBRATORS	DLJ	1998-12-15	View
510(k)	K983703	MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE	DJR	1998-12-11	View
510(k)	K983700	MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE	JXN	1998-12-11	View
510(k)	K983697	MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE	DIO	1998-12-11	View
510(k)	K983699	MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES	DKZ	1998-12-11	View
510(k)	K983701	MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS	LDJ	1998-12-11	View
510(k)	K983388	ONTRAK TESTCUP-ER	DIO	1998-11-18	View
510(k)	K983174	ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES	JXM	1998-11-18	View
510(k)	K983387	ONTRAK TESTCUP AND TESTSTIK CONTROLS	DIF	1998-10-09	View
510(k)	K982848	COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT	MRR	1998-10-01	View
510(k)	K982382	COBAS INTEGRA REAGENT CASSETTES	CFN	1998-09-28	View
510(k)	K981897	ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE	CJE	1998-08-26	View
510(k)	K982551	ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN	DIS	1998-08-18	View
510(k)	K982087	ROCHE CRP T CONTROL N	DCK	1998-08-18	View
510(k)	K980996	COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF)	KHS	1998-06-05	View
510(k)	K981585	ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT)	LDJ	1998-05-28	View