FDA 510(k) Application Details - K973351

Device Classification Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer   More FDA Info for this Device
510(K) Number	K973351
Device Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Applicant	BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 CONCORD, CA 94524-4117 US Other 510(k) Applications for this Company
Contact	Patricia M Klimley Other 510(k) Applications for this Contact
Regulation Number	866.6010   More FDA Info for this Regulation Number
Classification Product Code	LOJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/1997
Decision Date	11/21/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review