FDA 510(k) Application Details - K970147

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K970147
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 CONCORD, CA 94524-4117 US Other 510(k) Applications for this Company
Contact	Yvette Lloyd Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/1997
Decision Date	02/10/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review