Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
145 devices
Cleared
Oct 05, 2000
ELECSYS DHEA-S CALSET
Chemistry
30d
Cleared
Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
Chemistry
75d
Cleared
Aug 22, 2000
ELECSYS HCG TEST SYSTEM
Chemistry
36d
Cleared
Aug 04, 2000
HDL CHOLESTEROL PLUS
Chemistry
164d
Cleared
Jul 24, 2000
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
Chemistry
265d
Cleared
Jul 13, 2000
ELECSYS INSULIN CALSET
Chemistry
21d
Cleared
Jun 28, 2000
ELECSYS INSULIN CALCHECK
Chemistry
9d
Cleared
May 18, 2000
THE CARDIAC READER SYSTEM
Chemistry
69d
Cleared
Mar 21, 2000
ELECSYS CORTISOL CALCHECK
Chemistry
28d
Cleared
Mar 17, 2000
ELECSYS B-CROSSLAPS CALCHECK
Chemistry
71d
Cleared
Mar 07, 2000
ELECSYS CORTISOL TEST SYSTEM
Chemistry
39d
Cleared
Feb 23, 2000
ACCU-CHEK COMPLETE METER
Chemistry
19d
Cleared
Feb 23, 2000
ACCU-CHEK ADVANTAGE METER
Chemistry
19d
Cleared
Dec 09, 1999
ACCU-CHEK SIMPLICITY SYSTEM
Chemistry
27d
Cleared
Sep 30, 1999
INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC
Chemistry
190d
Cleared
Sep 28, 1999
ELECSYS PARATHYROID HORMONE TEST SYSTEM
Chemistry
49d
Cleared
Sep 24, 1999
ELECSYS ESTRADIOL CALSET II
Chemistry
21d
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
Mar 22, 1999
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.)
Chemistry
38d
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