FDA 510(k) Application Details - K081319

Device Classification Name	Calibrator, Secondary   More FDA Info for this Device
510(K) Number	K081319
Device Name	Calibrator, Secondary
Applicant	Siemens Healthcare Diagnostics Inc. 500 GBC DRIVE MS 514 NEWARK, DE 19702 US Other 510(k) Applications for this Company
Contact	GEORGE M PLUMMER Other 510(k) Applications for this Contact
Regulation Number	862.1150   More FDA Info for this Regulation Number
Classification Product Code	JIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/12/2008
Decision Date	08/04/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review