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."
1–24 of 264
Cleared Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · NBW
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Oct 05, 2010
ELECSYS CA 19-9 CALCHECK 5
K101365 · JJX
Roche Diagnostics Corp.
Immunology · 141d
Cleared Sep 09, 2010
COBAS 8000 MODULAR SERIES ANALYZER
K100853 · DCF
Roche Diagnostics Corp.
Chemistry · 167d
Cleared Aug 27, 2010
ACCU-CHEK ULTRFLEX INFUSION SET
K101196 · FPA
Roche Diagnostics Corp.
General Hospital · 120d
Cleared Jul 28, 2010
AMPHETAMINES II ASSAY
K093664 · DKZ
Roche Diagnostics Corp.
Chemistry · 243d
Cleared Jun 11, 2010
ELECSYS INSULIN CALCHECK 5
K101075 · JJX
Roche Diagnostics Corp.
Chemistry · 53d
Cleared Apr 23, 2010
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · CDZ
Roche Diagnostics Corp.
Chemistry · 171d
Cleared Mar 19, 2010
ELECSYS TROPONIN T CALCHECK 5
K092848 · JJX
Roche Diagnostics Corp.
Chemistry · 184d
Cleared Mar 05, 2010
COAGUCHEK XS PLUS PST SYSTEM
K092940 · GJS
Roche Diagnostics Corp.
Hematology · 162d
Cleared Mar 04, 2010
ELECSYS HCG STAT CALCHECK 5
K093700 · JJX
Roche Diagnostics Corp.
Chemistry · 93d
Cleared Feb 04, 2010
ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS...
K092649 · NBC
Roche Diagnostics Corp.
Chemistry · 160d
Cleared Feb 03, 2010
AMPHETAMINES II
K083764 · DKZ
Roche Diagnostics Corp.
Chemistry · 412d
Cleared Nov 10, 2009
ELECSYS TOXO IGG CALCHECK 5
K092888 · JJX
Roche Diagnostics Corp.
Microbiology · 50d
Cleared Sep 25, 2009
ELECYS ANTI-CCP CALCHECK
K091601 · JJX
Roche Diagnostics Corp.
Chemistry · 114d
Cleared Jun 19, 2009
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE...
K082340 · CGN
Roche Diagnostics Corp.
Chemistry · 308d
Cleared Mar 18, 2009
C-REACTIVE PROTEIN (LATEX)
K083444 · DCN
Roche Diagnostics Corp.
Immunology · 117d
Cleared Dec 05, 2008
ELECSYS RUBELLA IGG IMMUNOASSAY
K072617 · LFX
Roche Diagnostics Corp.
Microbiology · 445d
Cleared Jul 28, 2008
ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB
K080092 · JZO
Roche Diagnostics Corp.
Immunology · 196d
Cleared Jun 20, 2008
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C...
K080811 · NDY
Roche Diagnostics Corp.
Chemistry · 88d
Cleared Jun 09, 2008
ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG
K073501 · LGD
Roche Diagnostics Corp.
Microbiology · 179d
Cleared May 15, 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
K080227 · MRZ
Roche Diagnostics Corp.
General Hospital · 106d
Cleared May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607 · JIX
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Apr 18, 2008
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
K072714 · LCP
Roche Diagnostics Corp.
Chemistry · 206d
Cleared Mar 25, 2008
CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET...
K080183 · DIF
Roche Diagnostics Corp.
Chemistry · 60d