FDA 510(k) Application Details - K153577

Device Classification Name	Radioimmunoassay, Testosterones And Dihydrotestosterone   More FDA Info for this Device
510(K) Number	K153577
Device Name	Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant	NanoEnTek USA Inc. 5627 Stoneridge Drive Suite 304 Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Jimmy Chen 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	12/15/2015
Decision Date	10/14/2016
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