FDA 510(k) Application Details - K982035

Device Classification Name	Azo Dye, Calcium   More FDA Info for this Device
510(K) Number	K982035
Device Name	Azo Dye, Calcium
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	862.1145   More FDA Info for this Regulation Number
Classification Product Code	CJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/10/1998
Decision Date	06/24/1998
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