FDA 510(k) Application Details - K042625

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K042625
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	ORION DIAGNOSTICA OY KOIVU MANKKAAN TIE 6 ESPOO 02200 FI Other 510(k) Applications for this Company
Contact	ANNIKHA RANTAMA Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2004
Decision Date	11/18/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review