FDA 510(k) Application Details - K081294

Device Classification Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K081294
Device Name	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. TARRYTOWN, NY 10591 US Other 510(k) Applications for this Company
Contact	PHILIP LIU Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	NQD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/07/2008
Decision Date	07/29/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review