BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

Dna Probe, Nucleic Acid Amplification, Chlamydia

BECTON DICKINSON & CO.

The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Probetec Chlamydia Trachomatis (ct) Q Amplified Dna Assay.

Pre-market Notification Details

Device IDK091724
510k NumberK091724
Device Name:BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY
ClassificationDna Probe, Nucleic Acid Amplification, Chlamydia
Applicant BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152
ContactSaba Modjarrad
CorrespondentSaba Modjarrad
BECTON DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152
Product CodeMKZ  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-06-11
Decision Date2009-11-13
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.