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."
25–48 of 264
Cleared Mar 21, 2008
COBAS LITHIUM
K063684 · NDW
Roche Diagnostics Corp.
Toxicology · 465d
Cleared Mar 06, 2008
ROCHE-CREACTIVE PROTEIN (LATEX)
K073277 · DCN
Roche Diagnostics Corp.
Immunology · 106d
Cleared Feb 27, 2008
ELECSYS PROBNP II CALCHECK
K080147 · JJX
Roche Diagnostics Corp.
Chemistry · 36d
Cleared Jan 31, 2008
HANDHELD BASE UNIT
K072920 · GJS
Roche Diagnostics Corp.
Hematology · 108d
Cleared Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · JGQ
Roche Diagnostics Corp.
Chemistry · 31d
Cleared Sep 12, 2007
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
K071644 · DLZ
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Jul 13, 2007
ROCHE ELECSYS PTH TEST SYSTEM
K070709 · CEW
Roche Diagnostics Corp.
Chemistry · 121d
Cleared May 25, 2007
ACCU-CHEK PERFORMA SYSTEM
K070585 · NBW
Roche Diagnostics Corp.
Chemistry · 85d
Cleared May 09, 2007
ACCU-CHEK SMART PIX
K062395 · NBW
Roche Diagnostics Corp.
Chemistry · 266d
Cleared Mar 20, 2007
ELECSYS PTH TEST SYSTEM
K070391 · CEW
Roche Diagnostics Corp.
Chemistry · 39d
Cleared Mar 19, 2007
TDM CONTROL SET, MODEL CAT# 04521536
K070200 · JJY
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
K062203 · GHH
Roche Diagnostics Corp.
Hematology · 225d
Cleared Jan 31, 2007
COBAS INTEGRA CERULOPLASMIN
K062379 · JJY
Roche Diagnostics Corp.
Chemistry · 169d
Cleared Jan 31, 2007
CERULOPLASMIN, MODEL 2055953
K062114 · CHN
Roche Diagnostics Corp.
Immunology · 191d
Cleared Jan 29, 2007
COAGUCHEK XS PT CONTROLS
K063823 · GGN
Roche Diagnostics Corp.
Hematology · 34d
Cleared Jan 29, 2007
COAGUCHEK XS SYSTEM
K062925 · GJS
Roche Diagnostics Corp.
Hematology · 123d
Cleared Dec 22, 2006
COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS...
K063543 · CIG
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Oct 13, 2006
PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS
K062972 · JJX
Roche Diagnostics Corp.
Chemistry · 14d
Cleared Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
K062319 · JIX
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Sep 11, 2006
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · CFR
Roche Diagnostics Corp.
Chemistry · 40d
Cleared Aug 23, 2006
ONLINE TDM PROCAINAMIDE
K060773 · LAR
Roche Diagnostics Corp.
Toxicology · 154d
Cleared Aug 16, 2006
TDM N-ACETYLPROCAINAMIDE
K060738 · LAN
Roche Diagnostics Corp.
Toxicology · 149d
Cleared Aug 11, 2006
ACCU-CHEK AVIVA TEST STRIPS
K060620 · NBW
Roche Diagnostics Corp.
Chemistry · 156d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289 · LSL
Roche Diagnostics Corp.
Microbiology · 258d