FDA 510(k) Application Details - K093784

Device Classification Name	Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2   More FDA Info for this Device
510(K) Number	K093784
Device Name	Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2
Applicant	ZEUS SCIENTIFIC, INC. P.O. BOX 38 RARITAN, NJ 08869 US Other 510(k) Applications for this Company
Contact	EWA NADOLCZAK Other 510(k) Applications for this Contact
Regulation Number	866.3510   More FDA Info for this Regulation Number
Classification Product Code	OPM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/09/2009
Decision Date	07/16/2010
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