FDA 510(k) Applications Submitted by Suzette Chance

FDA 510(k) Number	Submission Date	Device Name	Applicant
K250218	01/24/2025	Xpert« FII & FV	Cepheid
K170284	01/30/2017	Great Basin Bordetella Direct Test	GREAT BASIN SCIENTIFIC, INC.
K230440	02/21/2023	Xpert« Xpress CoV-2 plus	Cepheid«
K250995	04/01/2025	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid«
K250996	04/01/2025	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid«
DEN240016	04/16/2024	Xpert HCV; GeneXpert Xpress System	Cepheid
K221160	04/21/2022	Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System	Cepheid
K231381	05/12/2023	Xpert Xpress MVP; GeneXpert Xpress 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
K242071	07/16/2024	Xpert Xpress CoV-2/Flu/RSV plus	Cepheid
K242109	07/19/2024	Xpert« Xpress CoV-2 plus (XPRS-COV2-10)	Cepheid«
K222638	09/01/2022	Xpert« Xpress GBS, GeneXpert« Dx System, GeneXpert« Infinity Systems	Cepheid
K243070	09/27/2024	Xpert« SA Nasal Complete	Cepheid«
K223046	09/29/2022	Xpert« FII & FV	Cepheid«
K243405	11/01/2024	Xpert vanA	Cepheid«
K243625	11/25/2024	Xpert MRSA/SA SSTI	Cepheid«
K243730	12/03/2024	Xpert C. difficile/Epi	Cepheid«
K163571	12/19/2016	Great Basin Stool Bacterial Pathogens Panel	Great Basin Scientific, Inc.
K071781	07/02/2007	PF4 IGG	GENETIC TESTING INSTITUTE