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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name herpes simplex virus nucleic acid amplification assay
510(k) Number K103798
Device Name BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
Applicant
BECTON DICKINSON & CO.
7 LOVETON CIR.
baltimore,  MD  21152
Applicant Contact thalia charles
Correspondent
BECTON DICKINSON & CO.
7 LOVETON CIR.
baltimore,  MD  21152
Correspondent Contact thalia charles
Regulation Number866.3305
Classification Product Code
OQO  
Date Received12/27/2010
Decision Date 03/18/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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