FDA 510(k) Application Details - K974306

Device Classification Name	Radioimmunoassay, Parathyroid Hormone   More FDA Info for this Device
510(K) Number	K974306
Device Name	Radioimmunoassay, Parathyroid Hormone
Applicant	SANGUI BIOTECH, INC. 1508 BROOKHOLLOW DR., #354 SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	JOHN J KIANG 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	11/17/1997
Decision Date	12/23/1997
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