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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
Contact kathryn babka carr
Regulation Number866.3390
Classification Product Code
LSL  
Date Received04/06/2009
Decision Date 06/05/2009
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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