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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 K140446
Device Name BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
Applicant
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Applicant Contact SHERMA WINSTON
Correspondent
BECTON, DICKINSON & CO.
7 LOVETON CIR.
SPARKS,  MD  21152 -0999
Correspondent Contact SHERMA WINSTON
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received02/21/2014
Decision Date 05/20/2014
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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