FDA 510(k) Application Details - K152422

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K152422
Device Name	Radioimmunoassay, Free Thyroxine
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	862.1695   More FDA Info for this Regulation Number
Classification Product Code	CEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/26/2015
Decision Date	02/17/2016
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