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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bacteriophage And Controls, B. Anthracis Lysis
510(k) Number K051794
Device Name GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRACIS
Applicant
Office of the Surgeon General, U.S. Army
1436 Porter St.
Office Of Regulatory Affairs
Fort Detrick,  MD  21702
Applicant Contact DIANE ULLMAN
Correspondent
Centers For Disease Control Nad Prevention
1600 Clifton Rd., NE
Ms H24-11
Atlanta,  GA  30329
Correspondent Contact Julie Villaneuva
Regulation Number866.3045
Classification Product Code
NVQ  
Date Received07/01/2005
Decision Date 08/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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