|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
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
|