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 IDK081824
510k NumberK081824
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 -0999
ContactKathryn B Carr
CorrespondentKathryn B Carr
BECTON, DICKINSON & CO. 7 LOVETON CIR. Sparks,  MD  21152 -0999
Product CodeMKZ  
CFR Regulation Number866.3120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-27
Decision Date2008-12-11
Summary:summary

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