FDA 510(k) Application Details - K102772

Device Classification Name	Mycophenolic Acid Test System   More FDA Info for this Device
510(K) Number	K102772
Device Name	Mycophenolic Acid Test System
Applicant	SIEMENS HEATLHCARE DIAGNOSTICS INC 500 GBC DRIVE M/S 514 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	HELEN M LEE Other 510(k) Applications for this Contact
Regulation Number	862.3840   More FDA Info for this Regulation Number
Classification Product Code	OAV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2010
Decision Date	10/07/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review