FDA 510(k) Application Details - K013837

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii   More FDA Info for this Device
510(K) Number	K013837
Device Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant	BIO-RAD 6565 185TH AVENUE NE REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	CHRISTOPHER BENTSEN 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	11/19/2001
Decision Date	09/30/2002
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