FDA 510(k) Application Details - K042442

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K042442
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	ORION DIAGNOSTICA OY KOIVU MANKKAAN TIE 6 ESPOO 02200 FI Other 510(k) Applications for this Company
Contact	ANNIKKA RANTAMA 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	09/09/2004
Decision Date	09/24/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review