Roche Diagnostics Corp. - FDA 510(k) Cleared Devices
264
Total
263
Cleared
1
Denied
264 devices
Cleared
Nov 16, 2001
TINA-QUANT APOLIPOPROTEIN VER.2
Chemistry
49d
Cleared
Nov 15, 2001
TINA-QUANT APOLIPOPROTEIN A-1 VER.2
Chemistry
45d
Cleared
Nov 13, 2001
TINA-QUANT APOLIPOPROTEIN B VER.2
Chemistry
49d
Cleared
Nov 05, 2001
ONTRAK TESTCARD 9
Toxicology
101d
Cleared
Nov 02, 2001
OMNI C ANALYZER
Chemistry
22d
Cleared
Sep 26, 2001
URISYS 2400 URINE TEST STRIP
Chemistry
61d
Cleared
Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
Immunology
55d
Cleared
Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
Immunology
54d
Cleared
Aug 24, 2001
MODIFICATION TO ELECSYS FSH II CALSET
Chemistry
28d
Cleared
Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
Chemistry
24d
Cleared
Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
Chemistry
19d
Cleared
Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
Chemistry
18d
Cleared
Jun 25, 2001
MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658
Chemistry
91d
Cleared
Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
Chemistry
66d
Cleared
Jun 20, 2001
ACCU-CHEK ACTIVE SYSTEM
Chemistry
15d
Cleared
May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
Hematology
46d
Cleared
May 10, 2001
CRP HS TEST SYSTEM
Immunology
190d
Cleared
May 01, 2001
TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315
Immunology
211d
Cleared
Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT...
Chemistry
121d
Cleared
Mar 28, 2001
ELECSYSCA 15-3 II ASSAY
Immunology
29d
Cleared
Mar 19, 2001
ACCU-CHEK INFORM METER
Chemistry
97d
Cleared
Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
Hematology
198d
Cleared
Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
Chemistry
29d
Cleared
Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
Chemistry
119d
Cleared
Feb 28, 2001
COBAS INTEGRA AMPHETAMINES
Toxicology
77d
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