FDA 510(k) Application Details - K031534

Device Classification Name	Radioimmunoassay, Parathyroid Hormone   More FDA Info for this Device
510(K) Number	K031534
Device Name	Radioimmunoassay, Parathyroid Hormone
Applicant	SCANTIBODIES LABORATORY, INC. 9336 ABRAHAM WAY SANTEE, CA 92071 US Other 510(k) Applications for this Company
Contact	RICHARD LENART 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	05/16/2003
Decision Date	07/30/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review