FDA 510(k) Application Details - K981305

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K981305
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. MELVILLE, NY 11747-3157 US Other 510(k) Applications for this Company
Contact	LAURA STORMS-TYLER 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	04/10/1998
Decision Date	05/07/1998
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