Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Feb 14, 2001
ELECSYS HCG+B CALCHECK
Chemistry
20d
Cleared
Jan 26, 2001
ELECSYS FSH CALSET II
Chemistry
85d
Cleared
Jan 25, 2001
ELECSYS HCG STAT CLASET II
Chemistry
35d
Cleared
Jan 17, 2001
ELECSYS DHEA-S
Chemistry
99d
Cleared
Jan 12, 2001
CA 125 II CALCHECK
Immunology
21d
Cleared
Jan 12, 2001
ELECSYS CA 125 II CALSET
Immunology
21d
Cleared
Dec 20, 2000
ELECSYS DHEA-S CALCHECK
Chemistry
14d
Cleared
Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
Hematology
74d
Cleared
Dec 18, 2000
ROCHE DIAGNOSTICS CK-MB
Chemistry
69d
Cleared
Dec 14, 2000
ELECSYS HCG AND BETA TEST SYSTEM
Chemistry
64d
Cleared
Nov 16, 2000
CREATININE PLUS
Chemistry
29d
Cleared
Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
Immunology
166d
Cleared
Oct 05, 2000
ELECSYS DHEA-S CALSET
Chemistry
30d
Cleared
Sep 06, 2000
COAGUCHEK S SYSTEM, MODEL 2138280
Hematology
258d
Cleared
Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
Chemistry
75d
Cleared
Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
Immunology
14d
Cleared
Aug 22, 2000
ELECSYS HCG TEST SYSTEM
Chemistry
36d
Cleared
Aug 10, 2000
ELECSYS CA 15-3 CALCHECK
Immunology
8d
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
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
Jun 28, 2000
ELECSYS INSULIN CALCHECK
Chemistry
9d
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