FDA.reportPublic FDA data

510(k) K100831

Device
CYFRA 21-1 EIA MODEL 211-10
Applicant
FUJIREBIO DIAGNOSTICS, INC
510(k) number
K100831
Product code
OVK  
Decision
Substantially Equivalent (SESE)
Decision date
2011-05-26
Date received
2010-03-24
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
STACEY DOLAN
Address
201 Great Valley Pkwy. Malvern PA US 19355 19355

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
K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor MarkerRoche Diagnostics2016-12-14

Legacy Summary#

summary

FDA Review#

Decision Summary