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U.S. Department of Health and Human Services

510(k) Premarket Notification
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111 to 120 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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bd minidraw capillary blood collection system with bd minidraw h&h capillary blood collection tube Becton Dickinson and Company K230493 11/27/2023
cardiophase® hscrp Siemens Healthcare Diagnostic Products GmbH K232624 11/27/2023
dxflex flow cytometer; clearllab 10c panels Beckman Coulter, Inc K232600 11/22/2023
quantisal™ oral fluid collection device Immunalysis Corporation K232898 11/21/2023
the sensitox b. anthracis toxin test First Light Diagnostics, Inc. K232545 11/20/2023
alinity c tricyclic antidepressants reagent kit Microgenics Corporation K231020 11/17/2023
aptima® chlamydia trachomatis assay Hologic, Inc. K230451 11/16/2023
great basin toxigenic c. difficile direct test (cdf2) Vela Operations USA K232092 11/14/2023
qscout lab; qscout rld Ad Astra Diagnostics, Inc. K230878 11/14/2023
ark hydrocodone assay ARK Diagnostics, Inc. K231752 11/09/2023

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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