Roche Diagnostic Systems, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Roche Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: MODIFICATION TO ABUSCREEN ONLINE BARBITURATES, MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES, MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
296
Total
296
Cleared
0
Denied
Roche Diagnostic Systems, Inc. has 296 FDA 510(k) cleared medical devices. Based in Mchenry, US.
Historical record: 296 cleared submissions from 1983 to 1999. Primary specialty: Toxicology.
Browse the FDA 510(k) cleared devices submitted by Roche Diagnostic Systems, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Roche Diagnostic Systems, Inc.
296 devices
Cleared
May 03, 1999
MODIFICATION TO ABUSCREEN ONLINE BARBITURATES
Toxicology
194d
Cleared
Feb 11, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES
Toxicology
113d
Cleared
Feb 10, 1999
MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE
Toxicology
112d
Cleared
Dec 15, 1998
ABUSCREEN ONLINE BENZ 200 CALIBRATORS
Toxicology
63d
Cleared
Dec 15, 1998
ABUSCREEN ONLINE BENZ 300 CALIBRATORS
Toxicology
63d
Cleared
Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE
Toxicology
51d
Cleared
Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES
Toxicology
51d
Cleared
Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
Toxicology
51d
Cleared
Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS
Toxicology
51d
Cleared
Dec 11, 1998
MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE
Toxicology
51d
Cleared
Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
Toxicology
69d
Cleared
Nov 18, 1998
ONTRAK TESTCUP-ER
Toxicology
54d
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