FDA 510(k) Application Details - K013420

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K013420
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	AWARENESS TECHNOLOGY, INC. 1995 SW MARTIN HWY. P.O. BOX 1679 PALM CITY, FL 34990 US Other 510(k) Applications for this Company
Contact	GLEN VAN SLOOTEN Other 510(k) Applications for this Contact
Regulation Number	862.1690   More FDA Info for this Regulation Number
Classification Product Code	JLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2001
Decision Date	07/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review