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FDA 510(k)

BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY

K-Number: K130268 · 2013-08-23

ApplicantBecton, Dickinson & CO
Decision Date2013-08-23
Product CodeOUY
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BD PROBETEC TRICHOMONAS VAGINALIS (TV) 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 2013-08-23 under 510(k) number K130268. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY?

BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY is a medical device that received FDA 510(k) clearance on 2013-08-23. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K130268.

When did BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY receive FDA 510(k) clearance?

BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY received FDA 510(k) clearance on 2013-08-23, under 510(k) number K130268.

Who is the listed applicant for BD PROBETEC TRICHOMONAS VAGINALIS (TV) 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 TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY?

The FDA product code for BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY is OUY.

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Related Devices (Code: OUY)

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.

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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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