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FDA 510(k)

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

K-Number: K091724 · 2009-11-13

ApplicantBecton, Dickinson & CO
Decision Date2009-11-13
Product CodeMKZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2009-11-13 under 510(k) number K091724. The device is classified under product code MKZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY?

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY is a medical device that received FDA 510(k) clearance on 2009-11-13. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K091724.

When did BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY receive FDA 510(k) clearance?

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY received FDA 510(k) clearance on 2009-11-13, under 510(k) number K091724.

Who is the listed applicant for BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY?

The FDA product code for BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY is MKZ.

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Related Devices (Code: MKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230451Aptima® Chlamydia trachomatis AssayHologic, Inc.K110923COBAS 4800 CT / NG TESTRoche Molecular Systems, Inc.K090824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAYBecton, Dickinson & COK081824BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAYBecton, Dickinson & COK080739ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KITAbbott Molecular, Inc.K070174AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORYRoche Diagnostics Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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