FDA 510(k) Application Details - K980525

Device Classification Name	Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids   More FDA Info for this Device
510(K) Number	K980525
Device Name	Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
Applicant	MARUKIN SHOYU CO., LTD. 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND Other 510(k) Applications for this Contact
Regulation Number	862.1187   More FDA Info for this Regulation Number
Classification Product Code	KWX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/11/1998
Decision Date	04/15/1998
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