FDA 510(k) Application Details - K152433

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K152433
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	ORTHO CLINICAL DIAGNOSTICS 100 INDIGO CREEK DRIVE ROCHESTER, NY 14626 US Other 510(k) Applications for this Company
Contact	Jessica Miller Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/27/2015
Decision Date	09/24/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review