FDA 510(k) Application Details - K014084

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K014084
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	PRIMUS CORP. P.O. BOX 22599 KANSAS CITY, MO 64114 US Other 510(k) Applications for this Company
Contact	JIM NOFFSINGER 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	12/11/2001
Decision Date	01/07/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review