FDA 510(k) Application Details - K030370

Device Classification Name	Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody   More FDA Info for this Device
510(K) Number	K030370
Device Name	Kit, Immunochromatographic, Bacillus Anthracis Differential Antibody
Applicant	TETRACORE, INC 11 FIRSTFIELD RD. SUITE C GAITHERSBURG,, MD 20878 US Other 510(k) Applications for this Company
Contact	BEVERLY L MANGOLD Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	NPO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/04/2003
Decision Date	12/09/2003
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