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U.S. Department of Health and Human Services

510(k) Premarket Notification
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41 to 50 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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vitek 2 ast-gram positive lefamulin (<=0.03 - >=4 µg/ml) bioMerieux, Inc. K234000 03/11/2024
rapid fentanyl (fyl) test strip, rapid fentanyl (fyl) test dipcard Co-Innovation Biotech Co.,Ltd. K231904 03/08/2024
safety sliding blood collection set Jiangsu Caina Medical Co., Ltd. K232781 03/07/2024
access free t4 Beckman Coulter, Inc K240273 03/06/2024
fastep fentanyl rapid test device (urine); fastep rapid fentanyl urine test (urine) Assure Tech LLC K240351 03/06/2024
stelo glucose biosensor system Dexcom, Inc. K234070 03/05/2024
access intact pth Beckman Coulter Inc K232791 03/01/2024
liaison plex respiratory flex assay Luminex Corporation K233410 03/01/2024
ark levetiracetam ii assay ARK Diagnostics, Inc. K232522 02/27/2024
dexcom g7 continuous glucose monitoring system Dexcom Inc. K234133 02/26/2024

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