FDA 510(k) Application Details - K130276

Device Classification Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use   More FDA Info for this Device
510(K) Number	K130276
Device Name	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS, INC. 500 GBC DRIVE M/S 514 P.O. BOX 6101 NEWARK, DE 19714-3026 US Other 510(k) Applications for this Company
Contact	PAMELA A JURGA Other 510(k) Applications for this Contact
Regulation Number	862.2160   More FDA Info for this Regulation Number
Classification Product Code	JJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2013
Decision Date	03/22/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review