FDA 510(k) Application Details - K033106

Device Classification Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2   More FDA Info for this Device
510(K) Number	K033106
Device Name	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
Applicant	TRINITY BIOTECH USA 2823 GIRTS RD. JAMESTOWN, NY 14701 US Other 510(k) Applications for this Company
Contact	Bonnie B DeJoy Other 510(k) Applications for this Contact
Regulation Number	866.3305   More FDA Info for this Regulation Number
Classification Product Code	MYF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2003
Decision Date	07/13/2004
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