FDA 510(k) Application Details - K981854

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K981854
Device Name	Calibrator, Secondary
Applicant	OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. MELVILLE, NY 11747 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	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/1998
Decision Date	08/18/1998
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