Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

491 results for "Roche Diagnostics"
73–96 of 491
Search insights Median review: 77d Cleared: 99% Top manufacturer: Roche Diagnostics Corp. Lead specialty: Chemistry
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
Cleared Jun 13, 2016
Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5
K160729 · PMT
Roche Diagnostics
Microbiology · 89d
Cleared May 25, 2016
Creatine Kinase
K160570 · JHS
Roche Diagnostics Operations (Rdo)
Chemistry · 86d
Cleared Apr 27, 2016
Elecsys Cortisol II, Cortisol II CalSet
K152227 · JFT
Roche Diagnostics
Chemistry · 264d
Cleared Apr 08, 2016
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K153301 · KXT
Roche Diagnostics
Chemistry · 147d
Cleared Jan 08, 2016
ONLINE TDM Vancomycin Gen.3
K152245 · LEH
Roche Diagnostics Operations (Rdo)
Chemistry · 151d
Cleared Oct 22, 2015
Carbamazepine Gen 4
K151578 · KLT
Roche Diagnostics Operations (Rdo)
Toxicology · 133d
Cleared Oct 02, 2015
Elecsys Progesterone III CalSet
K152526 · JIT
Roche Diagnostics
Chemistry · 29d
Cleared Sep 24, 2015
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
K151786 · CDD
Roche Diagnostics
Chemistry · 85d
Cleared Aug 13, 2015
Accu-Chek FlexLink Plus infusion set
K143446 · FPA
Roche Diagnostics GmbH
General Hospital · 254d
Cleared May 01, 2015
Elecsys Progesterone III Cal Check 5
K150955 · JJX
Roche Diagnostics
Chemistry · 22d
Cleared Mar 16, 2015
ACCU-CHEK CONNECT DIABETES MANAGEMENT APP
K141929 · NDC
Roche Diagnostics Corporation
General Hospital · 243d
Cleared Mar 03, 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K141867 · NBW
Roche Diagnostics
Chemistry · 236d