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510(k) K160915

Device
Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker
Applicant
ROCHE DIAGNOSTICS
510(k) number
K160915
Product code
OVK  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-14
Date received
2016-04-01
Regulation
866.6010
Classification name
Cytokeratin Fragments 21-1 Eia Kit
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Adam Clark
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250925ADVIA Centaur Cytokeratin Fragment 21-1Fujirebio Diagnostics,Inc.2025-12-16
K100831CYFRA 21-1 EIA MODEL 211-10Fujirebio Diagnostics,Inc.2011-05-26

Legacy Summary#

summary

FDA Review#

Decision Summary