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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dna probe, nucleic acid amplification, chlamydia
510(K) Number K091724
Device Name BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
Applicant
BECTON DICKINSON & CO.
7 loveton cir.
sparks,  MD  21152
Contact saba modjarrad
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received06/11/2009
Decision Date 11/13/2009
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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