Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Sep 28, 1999
ELECSYS PARATHYROID HORMONE TEST SYSTEM
Chemistry
49d
Cleared
Sep 24, 1999
ELECSYS ESTRADIOL CALSET II
Chemistry
21d
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 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1
Chemistry
49d
Cleared
Apr 14, 1999
INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B
Chemistry
49d
Cleared
Apr 13, 1999
ONTRAK TESTCUP-ER M2K
Toxicology
62d
Cleared
Mar 22, 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
Chemistry
38d
Cleared
Feb 26, 1999
ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544,...
Toxicology
18d
Cleared
Feb 23, 1999
ONTRAK TESTCUP-5 M2K
Toxicology
20d
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