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U.S. Department of Health and Human Services

510(k) Premarket Notification
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21 to 30 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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instastrip fentanyl rapid test (urine); instastrip fentanyl dipstick test (urine) Instanosis Inc K240295 03/28/2024
arx liquid amies collection & transport system ARX Sciences, Inc. K222613 03/27/2024
i-stat tbi cartridge with the i-stat alinity system Abbott Point of Care K234143 03/27/2024
qstat cartridge HemoSonics LLC K240045 03/27/2024
biofire spotfire respiratory/sore throat (r/st) panel BioFire Diagnostics, LLC K232954 03/26/2024
spotfire rsp pos & neg controls (m425), spotfire rsp positive control (m42638), spotfire rsp negative control (m42738) Maine Molecular Quality Controls, Inc. K233611 03/26/2024
elecsys pth , elecsys pth stat Roche Diagnostics K231927 03/22/2024
quickvue covid-19 test Quidel Corporation K231795 03/22/2024
thermo scientific oxoid rezafungin disc (5 µg) rzf5 Oxoid Limited (Part of Thermo Fisher Scientific) K231806 03/22/2024
allsource drug detector fentest; allsource drug detector fentanyl test AllSource Screening Solutions K234006 03/21/2024

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