FDA 510(k) Application Details - K043125

Device Classification Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes   More FDA Info for this Device
510(K) Number	K043125
Device Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
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	862.1050   More FDA Info for this Regulation Number
Classification Product Code	CIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2004
Decision Date	05/04/2005
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