FDA.reportPublic FDA data

510(k) K250925

Device
ADVIA Centaur Cytokeratin Fragment 21-1
Applicant
Fujirebio Diagnostics,Inc.
510(k) number
K250925
Product code
OVK
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-16
Date received
2025-03-27
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
N

Applicant Contact#

Contact
Kristin Maddaloni
Address
201 Great Valley Pkwy. Malvern PA US 19475 19475

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
K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics2016-12-14
K100831CYFRA 21-1 EIA MODEL 211-10Fujirebio Diagnostics,Inc.2011-05-26