FDA 510(k) Application Details - K100433

Device Classification Name	Antibody Igm,If, Cytomegalovirus Virus   More FDA Info for this Device
510(K) Number	K100433
Device Name	Antibody Igm,If, Cytomegalovirus Virus
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD WEST SACRAMENTO, CA 95691 US Other 510(k) Applications for this Company
Contact	ROBERT C EUSEBIO Other 510(k) Applications for this Contact
Regulation Number	866.3175   More FDA Info for this Regulation Number
Classification Product Code	LKQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/16/2010
Decision Date	05/13/2010
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