FDA 510(k) Application Details - K030329

Device Classification Name	Radioimmunoassay, Free Thyroxine   More FDA Info for this Device
510(K) Number	K030329
Device Name	Radioimmunoassay, Free Thyroxine
Applicant	Qualigen, Inc. 2042 CORTE DEL NOGAL CARLSBAD, CA 92009-1410 US Other 510(k) Applications for this Company
Contact	DOROTHY DEINZER 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	01/31/2003
Decision Date	07/03/2003
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