FDA 510(k) Application Details - K121907

Device Classification Name	Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes   More FDA Info for this Device
510(K) Number	K121907
Device Name	Alpha-Naphthyl Phosphate, Alkaline Phosphatase Or Isoenzymes
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS P.O. BOX 6101, MAILSTAP 514 NEWARK, DE 19714 US Other 510(k) Applications for this Company
Contact	ROSE T MARINELLI Other 510(k) Applications for this Contact
Regulation Number	862.1050   More FDA Info for this Regulation Number
Classification Product Code	CJO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2012
Decision Date	07/23/2012
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