FDA 510(k) Application Details - K031606

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Rubella   More FDA Info for this Device
510(K) Number	K031606
Device Name	Enzyme Linked Immunoabsorbent Assay, Rubella
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	LYNN WEIST Other 510(k) Applications for this Contact
Regulation Number	866.3510   More FDA Info for this Regulation Number
Classification Product Code	LFX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2003
Decision Date	06/20/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review