FDA 510(k) Application Details - K063605

Device Classification Name	Radioimmunoassay, Parathyroid Hormone   More FDA Info for this Device
510(K) Number	K063605
Device Name	Radioimmunoassay, Parathyroid Hormone
Applicant	Tosoh BioScience, Inc. 3600 GANTZ ROAD GROVE CITY, OH 43123 US Other 510(k) Applications for this Company
Contact	CHARLES P GILL Other 510(k) Applications for this Contact
Regulation Number	862.1545   More FDA Info for this Regulation Number
Classification Product Code	CEW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2006
Decision Date	06/21/2007
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