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U.S. Department of Health and Human Services

510(k) Premarket Notification
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51 to 60 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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xprecia stride coagulation system, xprecia system pt controls SIEMENS HEALTHCARE DIAGNOSTICS K151964 09/30/2016
xprecia prime coagulation system Universal Biosensors Pty Ltd K230802 03/15/2024
xpert® xpress gbs, genexpert® dx system, genexpert® infinity systems Cepheid K222638 09/27/2023
xpert® xpress cov-2 plus Cepheid® K230440 10/13/2023
xpert® tv assay on the cepheid genexpert instrument systems (genexpert dx, genexpert infinity-48, genexpert infinity-48s, and genexpertinfinity-80 systems), xpert vaginal/endocervical specimen collection kit, and xpert urine specimen collection kit CEPHEID K151565 10/16/2015
xpert® fii & fv Cepheid® K223046 02/15/2023
xpert, genexpert dx system CEPHEID K060540 07/25/2006
xpert xpress strep a Cepheid K172126 09/25/2017
xpert xpress strep a Cepheid K173398 04/26/2018
xpert xpress mvp; genexpert xpress system Cepheid K231381 10/19/2023

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