Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
52 devices
Cleared
Jul 16, 2002
ONLINE DAT II METHADONE II
Toxicology
68d
Cleared
Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
Toxicology
68d
Cleared
Jul 12, 2002
ROCHE ONLINE GENTAMICIN
Toxicology
130d
Cleared
Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
Toxicology
41d
Cleared
Jan 08, 2002
ROCHE ACETAMINOPHEN
Toxicology
56d
Cleared
Dec 21, 2001
ABUSCREEN ONLINE OPIATES 300 / 2000
Toxicology
63d
Cleared
Nov 05, 2001
ONTRAK TESTCARD 9
Toxicology
101d
Cleared
Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
Toxicology
77d
Cleared
Jul 12, 2000
ONTRAK TESTCUP 501, MODEL 3016633
Toxicology
68d
Cleared
Jul 10, 2000
ONTRAK TESTCUP PRO-5, MODEL 1986678
Toxicology
73d
Cleared
Jun 29, 2000
ONTRAK TESTCUP 502, MODEL 3016641
Toxicology
55d
Cleared
Apr 26, 2000
ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686
Toxicology
104d
Cleared
Apr 13, 2000
ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579
Toxicology
126d
Cleared
Apr 07, 2000
ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595
Toxicology
120d
Cleared
Jan 27, 2000
ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1
Toxicology
62d
Cleared
Jan 27, 2000
ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2
Toxicology
62d
Cleared
Jan 27, 2000
ONTRAK TESTCUP 5, CAT. 07 6481 7
Toxicology
62d
Cleared
Nov 23, 1999
ROCHE COBAS INTEGRA OPIATES 300/2000
Toxicology
88d
Cleared
Jul 22, 1999
COBAS INTEGRA AMIKACIN MAB
Toxicology
73d
Cleared
Jul 22, 1999
COBAS INTEGRA ACETAMINOPHEN
Toxicology
73d
Cleared
Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BARBITURATES
Toxicology
57d
Cleared
Jun 22, 1999
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
Toxicology
57d
Cleared
Apr 15, 1999
ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8
Toxicology
65d
Cleared
Apr 15, 1999
ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K)
Toxicology
65d
Cleared
Apr 13, 1999
ONTRAK TESTCUP-ER M2K
Toxicology
62d