FDA 510(k) Application Details - K062746

Device Classification Name	Ferritin, Antigen, Antiserum, Control   More FDA Info for this Device
510(K) Number	K062746
Device Name	Ferritin, Antigen, Antiserum, Control
Applicant	MEDICON HELLAS S.A. 5-7 MELITONA ST. GERAKAS, ATTIKI 15344 GR Other 510(k) Applications for this Company
Contact	GEORGE PSICHAS Other 510(k) Applications for this Contact
Regulation Number	866.5340   More FDA Info for this Regulation Number
Classification Product Code	DBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/14/2006
Decision Date	11/20/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review