FDA 510(k) Application Details - K111452

Device Classification Name	More FDA Info for this Device
510(K) Number	K111452
Device Name	PRESAGE ST2 ASSAY
Applicant	CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG 3030 BUNKER HILL STREET SUITE 115A SAN DIEGO, CA 92109 US Other 510(k) Applications for this Company
Contact	JAMES SNIDER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2011
Decision Date	12/09/2011
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