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FDA 510(k)

BD MAX Vaginal Panel

K-Number: K191957 · 2019-10-21

ApplicantGeneohm Sciences Canada, Inc. (Bd Diagnostics)
Decision Date2019-10-21
Product CodePQA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD MAX Vaginal Panel is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). It received FDA 510(k) clearance on 2019-10-21 under 510(k) number K191957. 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 MAX Vaginal Panel?

BD MAX Vaginal Panel is a medical device that received FDA 510(k) clearance on 2019-10-21. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Diagnostics). The 510(k) number is K191957.

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

BD MAX Vaginal Panel received FDA 510(k) clearance on 2019-10-21, under 510(k) number K191957.

Who is the listed applicant for BD MAX Vaginal Panel?

The FDA 510(k) record lists Geneohm Sciences Canada, Inc. (Bd Diagnostics) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD MAX Vaginal Panel?

The FDA product code for BD MAX Vaginal Panel is PQA.

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.K243725BD Vaginal PanelBecton, Dickinson and CompanyK243345Aptima 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 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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