FDA 510(k) Application Details - K172287

Device Classification Name	More FDA Info for this Device
510(K) Number	K172287
Device Name	ipsogen JAK2 RGQ PCR Kit
Applicant	QIAGEN, Inc. 19300 Germantown Road Germantown, MD 20874 US Other 510(k) Applications for this Company
Contact	Lindsey Howard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/28/2017
Decision Date	01/12/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MG -
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review