FDA 510(k) Application Details - K100831

Device Classification Name	More FDA Info for this Device
510(K) Number	K100831
Device Name	CYFRA 21-1 EIA MODEL 211-10
Applicant	FUJIREBIO DIAGNOSTICS, INC 201 GREAT VALLEY PARKWAY MALVERN, PA 19355-1307 US Other 510(k) Applications for this Company
Contact	STACEY DOLAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2010
Decision Date	05/26/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review