FDA 510(k) Application Details - K033426

Device Classification Name	Radioimmunoassay, Parathyroid Hormone   More FDA Info for this Device
510(K) Number	K033426
Device Name	Radioimmunoassay, Parathyroid Hormone
Applicant	DIASORIN, INC. 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	DAVID M IKEDA 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	10/27/2003
Decision Date	02/12/2004
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