FDA 510(k)

BD MAX Vaginal Panel

Numéro K : K191957 · 2019-10-21

DemandeurGeneohm Sciences Canada, Inc. (Bd Diagnostics)

Date de décision2019-10-21

Code produitPQA

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : PQA)

K260021cobas® BV/CVRoche Molecular Systems, Inc.K243725BD Vaginal PanelBecton, Dickinson and Company K243345Assay Aptima BV; Assay Aptima CV/TVHologic, Inc.K231381Xpert Xpress MVP; GeneXpert Xpress SystemCepheid K223653BD Vaginal PanelBecton, Dickinson and Company K221160Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity SystemCepheid

Source officielle

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