Search FDA 510(k) Devices
4,872 clearances indexed · Search by device name, K-number, manufacturer or product code
479
results for "Roche Diagnostics"
Cleared
Aug 23, 2006
ONLINE TDM PROCAINAMIDE
Roche Diagnostics Corp.
Toxicology
154d
Cleared
Aug 16, 2006
TDM N-ACETYLPROCAINAMIDE
Roche Diagnostics Corp.
Toxicology
149d
Cleared
Aug 11, 2006
COAGUCHEK XS SYSTEM
Roche Diagnostics
Hematology
123d
Cleared
Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
Roche Diagnostics Corp.
Chemistry
156d
Cleared
Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Roche Diagnostics Corp.
Microbiology
258d
Cleared
Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Roche Diagnostics Corp.
Microbiology
258d
Cleared
Aug 08, 2006
ONLINE VALPROIC ACID
Roche Diagnostics Corp.
Toxicology
146d
Cleared
Jul 21, 2006
TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM
Roche Diagnostics Corp.
Chemistry
36d
Cleared
Jul 03, 2006
CHOLINESTERASE GEN.2 TEST SYSTEM
Roche Diagnostics Corp.
Toxicology
75d
Cleared
Jun 09, 2006
ONLINE TDM TOBRAMYCIN
Roche Diagnostics Corp.
Toxicology
72d
Cleared
May 30, 2006
PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS...
Roche Diagnostics Corp.
Toxicology
81d
Cleared
May 17, 2006
COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM
Roche Diagnostics Corp.
Chemistry
30d
Cleared
May 11, 2006
ENZYME IMMUNOASSAY, VANCOMYCIN
Roche Diagnostics Corp.
Toxicology
65d
Cleared
May 03, 2006
ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH
Roche Diagnostics Corp.
Chemistry
57d
Cleared
Apr 18, 2006
ELECSYS TSH CALSET W/MODELS 04738551
Roche Diagnostics Corp.
Chemistry
28d
Cleared
Apr 10, 2006
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
Roche Diagnostics Corp.
Chemistry
20d
Cleared
Mar 15, 2006
TDM CONTROL SET
Roche Diagnostics Corp.
Chemistry
22d
Cleared
Mar 13, 2006
COBAS 6000 SERIES SYSTEM
Roche Diagnostics
Immunology
28d
Cleared
Feb 16, 2006
COBAS INTEGRA CHLORIDE ELCTRODE GEN.2
Roche Diagnostics Corp.
Chemistry
34d
Cleared
Feb 09, 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA...
Roche Diagnostics Corp.
Chemistry
48d
Cleared
Feb 07, 2006
ROCHE ELECSYS ANTI-TG
Roche Diagnostics Corp.
Immunology
61d
Cleared
Dec 14, 2005
ISE INDIRECT NA, K, CL FOR GEN.2
Roche Diagnostics Corp.
Chemistry
30d
Cleared
Dec 05, 2005
ELECSYS PROBNP IMMUNOASSAY
Roche Diagnostics Corp.
Chemistry
192d
Cleared
Nov 28, 2005
ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK
Roche Diagnostics
Chemistry
28d