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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 K081824
Device Name BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) 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 Number866.3120
Classification Product Code
MKZ  
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
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