FDA 510(k) Application Details - DEN200059

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN200059
Device Name	POMC/PCSK1/LEPR CDx Panel
Applicant	PreventionGenetics, LLC 3800 S. Business Park Avenue Marshfield, WI 54449 US Other 510(k) Applications for this Company
Contact	Jerry Machado Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/18/2020
Decision Date	01/21/2022
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