Search FDA 510(k) Devices

4,872 clearances indexed · Search by device name, K-number, manufacturer or product code

479 results for "Roche Diagnostics"
217–240 of 479
Cleared Oct 19, 2007
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · JGQ
Roche Diagnostics Corp.
Chemistry · 31d
Cleared Oct 05, 2007
ELECSYS CORTISOL TEST SYSTEM
K070788 · NHG
Roche Diagnostics
Chemistry · 197d
Cleared Sep 14, 2007
TOTAL PROTEIN URINE/CSF GEN.3
K071239 · JGQ
Roche Diagnostics
Chemistry · 134d
Cleared Sep 12, 2007
ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620
K071644 · DLZ
Roche Diagnostics Corp.
Toxicology · 89d
Cleared Jul 30, 2007
COBAS C 111 ANALYZER
K071211 · CIT
Roche Diagnostics
Chemistry · 90d
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 11, 2007
COAGUCHEK XS PLUS SYSTEM
K071041 · GJS
Roche Diagnostics
Hematology · 29d
Cleared May 09, 2007
ACCU-CHEK SMART PIX
K062395 · NBW
Roche Diagnostics Corp.
Chemistry · 266d
Cleared Apr 17, 2007
AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K070172 · LSL
Roche Diagnostics Corporation
Microbiology · 89d
Cleared Apr 16, 2007
AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
K070174 · MKZ
Roche Diagnostics Corporation
Microbiology · 88d
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 Feb 16, 2007
ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
K063520 · OAV
Roche Diagnostics
Toxicology · 87d
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 31, 2006
ELECSYS IGE II IMMUNOASSAY
K061970 · JHR
Roche Diagnostics
Immunology · 50d