FDA 510(k) Applications Submitted by Suzette Chance

FDA 510(k) Number Submission Date Device Name Applicant
K170284 01/30/2017 Great Basin Bordetella Direct Test GREAT BASIN SCIENTIFIC, INC.
K221160 04/21/2022 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System Cepheid
K231481 05/23/2023 Xpert Xpress CoV-2/Flu/RSV plus Cepheid«
K212213 07/15/2021 Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System Cepheid
K222638 09/01/2022 Xpert« Xpress GBS, GeneXpert« Dx System, GeneXpert« Infinity Systems Cepheid
K223046 09/29/2022 Xpert« FII & FV Cepheid«
K163571 12/19/2016 Great Basin Stool Bacterial Pathogens Panel Great Basin Scientific, Inc.
K071781 07/02/2007 PF4 IGG GENETIC TESTING INSTITUTE


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