FDA 510(k) Application Details - K944867

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii   More FDA Info for this Device
510(K) Number	K944867
Device Name	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant	BIO-WHITTAKER, INC., A CAMBREX CO. 8830 BIGGS FORD RD. WALKERSVILLE, MD 21793-8415 US Other 510(k) Applications for this Company
Contact	LEIF E OLSEN 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	09/27/1994
Decision Date	05/14/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review