Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
264
results for "Roche Diagnostics Corp."
Cleared
May 12, 2003
ELECSYS LH CALSET II
Roche Diagnostics Corp.
Chemistry
18d
Cleared
Apr 28, 2003
ROCHE ONLINE TDM PHENYTOIN
Roche Diagnostics Corp.
Toxicology
77d
Cleared
Apr 11, 2003
ONLINE DAT II CANNABINOIDS II
Roche Diagnostics Corp.
Toxicology
80d
Cleared
Apr 01, 2003
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
Roche Diagnostics Corp.
Hematology
22d
Cleared
Dec 19, 2002
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
Roche Diagnostics Corp.
Chemistry
7d
Cleared
Dec 06, 2002
ONLINE DAT II COCAINE II
Roche Diagnostics Corp.
Toxicology
66d
Cleared
Nov 29, 2002
ELECSYS PROBNP CALCHECK
Roche Diagnostics Corp.
Chemistry
256d
Cleared
Nov 25, 2002
COBAS INTEGRA ONLINE DAT II COCAINE II
Roche Diagnostics Corp.
Toxicology
54d
Cleared
Nov 19, 2002
ELECSYS PROBNP IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
112d
Cleared
Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
Roche Diagnostics Corp.
Hematology
193d
Cleared
Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND...
Roche Diagnostics Corp.
Hematology
224d
Cleared
Sep 09, 2002
ELECSYS CORTISOL TEST SYSTEM
Roche Diagnostics Corp.
Chemistry
145d
Cleared
Aug 29, 2002
MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB
Roche Diagnostics Corp.
Chemistry
20d
Cleared
Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
Roche Diagnostics Corp.
Immunology
157d
Cleared
Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
Roche Diagnostics Corp.
Chemistry
20d
Cleared
Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
Roche Diagnostics Corp.
Toxicology
68d
Cleared
Jul 16, 2002
ONLINE DAT II METHADONE II
Roche Diagnostics Corp.
Toxicology
68d
Cleared
Jul 12, 2002
ROCHE ONLINE GENTAMICIN
Roche Diagnostics Corp.
Toxicology
130d
Cleared
Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Roche Diagnostics Corp.
Chemistry
29d
Cleared
Jun 11, 2002
ACCU-CHEK ADVANTAGE MODULE
Roche Diagnostics Corp.
Chemistry
33d
Cleared
Jun 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
Roche Diagnostics Corp.
Chemistry
28d
Cleared
Apr 16, 2002
ROCHE ONLINE THEOPHYLLINE
Roche Diagnostics Corp.
Toxicology
41d
Cleared
Mar 21, 2002
DIABETES ASSISTANT SOFTWARE
Roche Diagnostics Corp.
Chemistry
94d
Cleared
Mar 06, 2002
ELECSYS ANTI-TG CALCHECK
Roche Diagnostics Corp.
Immunology
30d