FDA 510(k) Application Details - K980853

Device Classification Name	Calibrators, Drug Mixture   More FDA Info for this Device
510(K) Number	K980853
Device Name	Calibrators, Drug Mixture
Applicant	BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. PLEASANTON, CA 94588-2722 US Other 510(k) Applications for this Company
Contact	BETSY SOARES-MADDOX Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/1998
Decision Date	04/21/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review