FDA 510(k) Application Details - K964368

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K964368
Device Name	Calibrator, Secondary
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. CONCORD, CA 94524 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	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/01/1996
Decision Date	06/16/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review