FDA 510(k) Application Details - K083175

Device Classification Name	System, Multipurpose For In Vitro Coagulation Studies   More FDA Info for this Device
510(K) Number	K083175
Device Name	System, Multipurpose For In Vitro Coagulation Studies
Applicant	SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 NEWARK, DE 19702 US Other 510(k) Applications for this Company
Contact	JANET M FOSE Other 510(k) Applications for this Contact
Regulation Number	864.5425   More FDA Info for this Regulation Number
Classification Product Code	JPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2008
Decision Date	01/26/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review