FDA 510(k) Application Details - K030044

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K030044
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	REFERENCE DIAGNOSTICS, INC. 19 CROSBY DR. SUITE 30 BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	JOSEPH LAWLOR 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	01/06/2003
Decision Date	09/30/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review