FDA 510(k) Application Details - DEN130042

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130042
Device Name	MISEQDX UNIVERSAL KIT 1.0
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	PFT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2013
Decision Date	11/19/2013
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review