FDA 510(k) Application Details - K101425

Device Classification Name	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems   More FDA Info for this Device
510(K) Number	K101425
Device Name	Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 1584 ENTERPRISE BLVD WEST SACRAMENTO, CA 95691 US Other 510(k) Applications for this Company
Contact	Elisabeth Warriner Other 510(k) Applications for this Contact
Regulation Number	866.1640   More FDA Info for this Regulation Number
Classification Product Code	LRG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2010
Decision Date	09/10/2010
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