FDA 510(k) Application Details - K124006

Device Classification Name	More FDA Info for this Device
510(K) Number	K124006
Device Name	ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
Applicant	ILLUMINA, INC. 5200 ILLUMINA WAY SAN DIEGO, CA 92122 US Other 510(k) Applications for this Company
Contact	LEANNE M KIVIHARJU Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PFR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/26/2012
Decision Date	11/19/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review