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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 K090827
Device Name BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
Original Applicant
BECTON, DICKINSON & CO.
7 loveton cir.
sparks,  MD  21152
Original Contact saba modjarrad
Regulation Number866.3390
Classification Product Code
LSL  
Date Received03/26/2009
Decision Date 05/27/2009
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
Recalls CDRH Recalls
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