FDA 510(k) Application Details - DEN190023

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190023
Device Name	AmplideX Fragile X Dx & Carrier Screen Kit
Applicant	Asuragen, Inc. 2150 Woodward, Suite 100 Austin, TX 78744 US Other 510(k) Applications for this Company
Contact	Bernard Andruss Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2019
Decision Date	02/21/2020
Decision	DENG -
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	MG -
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review