FDA 510(k) Application Details - K090236

Device Classification Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer   More FDA Info for this Device
510(K) Number	K090236
Device Name	Kit, Test,Alpha-Fetoprotein For Testicular Cancer
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 NEWARK, DE 19702 US Other 510(k) Applications for this Company
Contact	JANET M FOSE 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	02/02/2009
Decision Date	04/27/2009
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