FDA 510(k) Applications for Medical Device Product Code "PQA"

FDA 510(k) Number Applicant Device Name Decision Date
K223653 Becton, Dickinson and Company BD Vaginal Panel 03/06/2023
K212213 Cepheid Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System 02/09/2022
K221160 Cepheid Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System 06/07/2022
DEN160001 GENEOHM SCIENCES CANADA , INC (BD DIAGNOSTICS) BD MAX Vaginal Panel, BD MAX Instrument 10/28/2016
K191957 GeneOhm Sciences Canada, Inc. (BD Diagnostics) BD MAX Vaginal Panel 10/21/2019
K201017 GeneOhm Sciences Canada, Inc. (BD Life Sciences) BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit 10/18/2021
K190452 Hologic, Inc. Aptima BV Assay 05/23/2019
K190472 Hologic, Inc. Aptima CV/TV Assay 05/16/2019


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