FDA 510(k) Application Details - K971537

Device Classification Name	Campylobacter Pylori   More FDA Info for this Device
510(K) Number	K971537
Device Name	Campylobacter Pylori
Applicant	ORION DIAGNOSTICA, DIV. ORION CORP. KOIVUMANKKAANTIE 6 ESPOO 02200 FI Other 510(k) Applications for this Company
Contact	ANNIKKA RANTAMA 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	04/28/1997
Decision Date	06/27/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review