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FDA 510(k)

BD Vaginal Panel

K-Number: K243725 · 2024-12-19

ApplicantBecton, Dickinson and Company
Decision Date2024-12-19
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD Vaginal Panel is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson and Company. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K243725. The device is classified under product code PQA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD Vaginal Panel?

BD Vaginal Panel is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Becton, Dickinson and Company. The 510(k) number is K243725.

When did BD Vaginal Panel receive FDA 510(k) clearance?

BD Vaginal Panel received FDA 510(k) clearance on 2024-12-19, under 510(k) number K243725.

Who is the listed applicant for BD Vaginal Panel?

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

What is the FDA product code for BD Vaginal Panel?

The FDA product code for BD Vaginal Panel is PQA.

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Other records listing Becton, Dickinson and Company as applicant

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Related Devices (Code: PQA)

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.

K260021cobas® BV/CVRoche Molecular Systems, Inc.K243345Aptima BV Assay; Aptima CV/TV AssayHologic, Inc.K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheidK223653BD Vaginal PanelBecton, Dickinson and CompanyK221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheidK212213Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

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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