FDA 510(k) Application Details - K051794

Device Classification Name Bacteriophage And Controls, B. Anthracis Lysis

  More FDA Info for this Device
510(K) Number K051794
Device Name Bacteriophage And Controls, B. Anthracis Lysis
Applicant OFFICE OF THE SURGEON GENERAL, U.S. ARMY
1436 PORTER STREET
OFFICE OF REGULATORY AFFAIRS
FORT DETRICK, MD 21702 US
Other 510(k) Applications for this Company
Contact DIANE ULLMAN
Other 510(k) Applications for this Contact
Regulation Number 000.0000

  More FDA Info for this Regulation Number
Classification Product Code NVQ
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 07/01/2005
Decision Date 08/16/2005
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

FDA Source Information for K051794


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact