FDA 510(k)

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit

Numéro K : K201017 · 2021-10-18

DemandeurGeneohm Sciences Canada, Inc. (Bd Life Sciences)

Date de décision2021-10-18

Code produitPQA

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is the device name listed in this FDA 510(k) record. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Life Sciences). It received FDA 510(k) clearance on 2021-10-18 under 510(k) number K201017. 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 System, BD Molecular Swab Collection Kit?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is a medical device that received FDA 510(k) clearance on 2021-10-18. The listed applicant is Geneohm Sciences Canada, Inc. (Bd Life Sciences). The 510(k) number is K201017.

When did BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit receive FDA 510(k) clearance?

BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit received FDA 510(k) clearance on 2021-10-18, under 510(k) number K201017.

Who is the listed applicant for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

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

What is the FDA product code for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit?

The FDA product code for BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit is PQA.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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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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