FDA 510(k) Application Details - K043460

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K043460
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	OLYMPUS AMERICA, INC. 3131 WEST ROYAL LN. IRVING, TX 75063-3104 US Other 510(k) Applications for this Company
Contact	BEV HARDING Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2004
Decision Date	01/31/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review