FDA 510(k) Application Details - K973523

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K973523
Device Name	Campylobacter Pylori
Applicant	BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 INDIANAPOLIS, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	MIKE FLIS Other 510(k) Applications for this Contact
Regulation Number	866.3110   More FDA Info for this Regulation Number
Classification Product Code	LYR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/1997
Decision Date	03/03/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review