FDA 510(k) Application Details - K961659

Device Classification Name	Calibrator, Multi-Analyte Mixture   More FDA Info for this Device
510(K) Number	K961659
Device Name	Calibrator, Multi-Analyte Mixture
Applicant	BOEHRINGER MANNHEIM CORP. BOEHRINGER MANNHEIM CO. 1059 KINGSMILL PARKWAY COLUMBUS, OH US Other 510(k) Applications for this Company
Contact	MARY KONING 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	04/30/1996
Decision Date	06/13/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review