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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 K090971
Device Name BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks,  MD  21152
Applicant Contact kathryn babka carr
Correspondent
BECTON, DICKINSON & CO.
7 loveton cir.
sparks,  MD  21152
Correspondent Contact kathryn babka carr
Regulation Number866.3390
Classification Product Code
LSL  
Date Received04/06/2009
Decision Date 06/05/2009
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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