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FDA 510(k)

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

K-Number: K090827 · 2009-05-27

ApplicantBecton, Dickinson & CO
Decision Date2009-05-27
Product CodeLSL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX 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 2009-05-27 under 510(k) number K090827. The device is classified under product code LSL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY?

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY is a medical device that received FDA 510(k) clearance on 2009-05-27. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K090827.

When did BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY receive FDA 510(k) clearance?

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY received FDA 510(k) clearance on 2009-05-27, under 510(k) number K090827.

Who is the listed applicant for BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX 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 NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY?

The FDA product code for BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY is LSL.

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Related Devices (Code: LSL)

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.

K231329Aptima Neisseria gonorrhoeae AssayHologic, Inc.K180681Aptima Combo 2 Assay (Panther System)Hologic, Inc.K173887cobas CT/NG for use on cobas 6800/8800 systemsRoche Molecular Systems, Inc.K173840Xpert CT/NGCepheidK163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc.K132270COBAS CT/NG V2.0 TESTRoche Molecular Systems, Inc.

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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