FDA 510(k) Application Details - K191462

Device Classification Name	More FDA Info for this Device
510(K) Number	K191462
Device Name	Proov Test
Applicant	MFB Fertility, Inc. 999 Sumner Way Erie, CO 80516 US Other 510(k) Applications for this Company
Contact	Amy Beckley Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/03/2019
Decision Date	02/27/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review