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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
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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
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