FDA 510(k) Application Details - K980908

Device Classification Name	Acid, Lactic, Enzymatic Method   More FDA Info for this Device
510(K) Number	K980908
Device Name	Acid, Lactic, Enzymatic Method
Applicant	KDK CORP. 57 NISHIAKETA-CHO, HIGASHI-KUJO, MINAMI-KU KYOTO 601 JP Other 510(k) Applications for this Company
Contact	KAZUO IKETAKI Other 510(k) Applications for this Contact
Regulation Number	862.1450   More FDA Info for this Regulation Number
Classification Product Code	KHP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/10/1998
Decision Date	09/11/1998
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