FDA 510(k) Application Details - K040407

Device Classification Name	Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis   More FDA Info for this Device
510(K) Number	K040407
Device Name	Enzyme Linked Immunoabsorbent Assay, Antibody, B. Anthracis
Applicant	IMMUNETICS, INC. 27 DRYDOCK AVENUE BOSTON, MA 02210 US Other 510(k) Applications for this Company
Contact	ANDREW LEVIN Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NRL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/17/2004
Decision Date	06/03/2004
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