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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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