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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dna-reagents, neisseria
510(k) Number K081825
Device Name BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY
Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks,  MD  21152 -0999
Applicant Contact kathryn b carr
Correspondent
BECTON, DICKINSON & CO.
7 loveton cir.
sparks,  MD  21152 -0999
Correspondent Contact kathryn b carr
Regulation Number866.3390
Classification Product Code
LSL  
Date Received06/27/2008
Decision Date 12/11/2008
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
Recalls CDRH Recalls
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