FDA 510(k) Application Details - K003259

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii   More FDA Info for this Device
510(K) Number	K003259
Device Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant	BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. CHASKA, MN 55318-1084 US Other 510(k) Applications for this Company
Contact	DENISE THOMPSON Other 510(k) Applications for this Contact
Regulation Number	866.3780   More FDA Info for this Regulation Number
Classification Product Code	LGD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2000
Decision Date	06/13/2001
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