FDA 510(k) Application Details - K063319

Device Classification Name	Hepatitis A Test (Antibody And Igm Antibody)   More FDA Info for this Device
510(K) Number	K063319
Device Name	Hepatitis A Test (Antibody And Igm Antibody)
Applicant	Bio-Rad Laboratories 3 BD RAYMOND POINCARE MARNES-LA-COQUETTE HAUTS-DE-SEINE 92430 FR Other 510(k) Applications for this Company
Contact	MANUELA KAUL Other 510(k) Applications for this Contact
Regulation Number	866.3310   More FDA Info for this Regulation Number
Classification Product Code	LOL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2006
Decision Date	05/03/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review