FDA 510(k) Application Details - K990658

Device Classification Name	Radioimmunoassay, Thyroid-Stimulating Hormone   More FDA Info for this Device
510(K) Number	K990658
Device Name	Radioimmunoassay, Thyroid-Stimulating Hormone
Applicant	LITTLE NELL LABS, INC. 1676 EAST SOPRIS CREEK RD. BASALT, CO 81621 US Other 510(k) Applications for this Company
Contact	JOEL R. L. EHRENKRANZ 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	03/01/1999
Decision Date	06/02/1999
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