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U.S. Department of Health and Human Services

510(k) Premarket Notification
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101 to 110 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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iflash-hcg; chemiluminescence immunoassay analyzer (model: iflash 3000-c) Shenzhen YHLO Biotech Co., LTD. K223690 12/11/2023
pronephro aki™ (ngal) BioPorto Diagnostic Inc. K232761 12/07/2023
q-pad test system Qurasense K231465 12/06/2023
bd veritor™ system for rapid detection of flu a+b clia waived kit BD K232434 12/05/2023
access hstni Beckman Coulter, Inc. K230648 12/04/2023
cobas sars-cov-2 nucleic acid test for use on the cobas liat system Roche Molecular Systems, Inc. K223783 12/04/2023
monarch blood collection set The Monarch Company K232308 12/04/2023
bd minidraw™ capillary blood collection system with bd minidraw™ sst™ capillary blood collection tube Becton Dickinson and Company K230391 12/01/2023
trueness™ air blood glucose monitoring system; trueness™ blood glucose monitoring system Sinocare Inc. K231476 12/01/2023
cue covid-19 molecular test Cue Health Inc. K232643 11/28/2023

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