Search FDA 510(k) Devices

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

479 results for "Roche Diagnostics"
49–72 of 479
Cleared Jun 22, 2018
Elecsys CA 15-3 II
K181492 · MOI
Roche Diagnostics
Immunology · 16d
Cleared Apr 19, 2018
CoaguChek XS Pro System
K180693 · GJS
Roche Diagnostics
Hematology · 34d
Cleared Apr 19, 2018
CoaguChek XS Plus System
K180684 · GJS
Roche Diagnostics
Hematology · 35d
Cleared Mar 02, 2018
cobas m 511 integrated hematology analyzer
K171655 · GKZ
Roche Diagnostics Hematology, Inc.
Hematology · 270d
Cleared Feb 20, 2018
Elecsys CA 15-3 II
K171605 · MOI
Roche Diagnostics
Immunology · 264d
Cleared Dec 25, 2017
CoaguChek Vantus System
K170960 · GJS
Roche Diagnostics
Hematology · 269d
Cleared Jul 28, 2017
cobas HbA1c Test, cobas b 101 system
K163633 · LCP
Roche Diagnostics Operations
Chemistry · 218d
Cleared Jun 23, 2017
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl
K162678 · LGD
Roche Diagnostics
Microbiology · 270d
Cleared May 26, 2017
Creatine Kinase-MB
K162526 · JHW
Roche Diagnostics
Chemistry · 259d
Cleared May 10, 2017
ALP IFCC Gen.2
K171080 · CJE
Roche Diagnostics Operations (Rdo)
Chemistry · 29d
Cleared Apr 26, 2017
CalSet IGF-1
K170938 · JIT
Roche Diagnostics
Chemistry · 27d
Cleared Apr 04, 2017
Beta-CrossLaps CalCheck 5
K170678 · JJX
Roche Diagnostics
Chemistry · 29d
Cleared Mar 17, 2017
Elecsys CMV IgM
K163569 · LFZ
Roche Diagnostics
Microbiology · 88d
Cleared Feb 08, 2017
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D...
K162840 · MRG
Roche Diagnostics
Chemistry · 120d
Cleared Jan 23, 2017
Elecsys TSH assay, cobas e 801 Immunoassay analyzer
K162606 · JLW
Roche Diagnostics
Chemistry · 126d
Cleared Jan 18, 2017
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet,...
K162895 · MMI
Roche Diagnostics
Chemistry · 93d
Cleared Jan 12, 2017
Elecsys CYFRA 21-1 CalCheck 5
K162173 · JJX
Roche Diagnostics
Immunology · 162d
Cleared Dec 19, 2016
cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay
K160571 · PDJ
Roche Diagnostics Operations (Rdo)
Chemistry · 294d
Not Cleared Dec 19, 2016
Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5
DEN150057 · PQO
Roche Diagnostics
Chemistry · 376d
Cleared Dec 14, 2016
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
K160915 · OVK
Roche Diagnostics
Immunology · 257d
Cleared Oct 19, 2016
HDL-Cholesterol Gen.4
K162593 · LBS
Roche Diagnostics Operations (Rdo)
Chemistry · 33d
Cleared Jul 28, 2016
Elecsys Syphilis
K160910 · LIP
Roche Diagnostics
Microbiology · 118d
Cleared Jul 27, 2016
Tina-quant Cystatin C Gen.2
K161817 · NDY
Roche Diagnostics Operations (Rdo)
Chemistry · 26d
Cleared Jun 15, 2016
ROMA Calculation Tool Using Elecsys Assays
K153607 · ONX
Roche Diagnostics
Immunology · 181d