FDA 510(k) Application Details - K030546

Device Classification Name	Calibrator, Primary   More FDA Info for this Device
510(K) Number	K030546
Device Name	Calibrator, Primary
Applicant	DENKA SEIKEN CO., LTD. KAGAMIDA FACILITY 1-2-2 MINAMIHONCHO, GOSEN CITY, NIIGATA 959-1695 JP Other 510(k) Applications for this Company
Contact	TOSHIMI MATSUNAGA Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2003
Decision Date	06/02/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review