FDA 510(k) Application Details - K182521

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K182521
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92011 US Other 510(k) Applications for this Company
Contact	Wajdi Abdul-Ahad Other 510(k) Applications for this Contact
Regulation Number	862.1680   More FDA Info for this Regulation Number
Classification Product Code	CDZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/13/2018
Decision Date	01/29/2019
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