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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
 
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dexcom g7 continuous glucose monitoring system Dexcom Inc. K240902 04/23/2024
freestyle libre 3 continuous glucose monitoring system; freestyle libre 2 flash glucose monitoring system Abbott Diabetes Care Inc. K233537 04/23/2024
access epo Beckman Coulter Inc K240182 04/22/2024
flowflex® plus covid-19 home test Acon Laboratories, Inc. K233373 04/19/2024
healgen rapid covid-19 antigen test Healgen Scientific LLC K232377 04/19/2024
aperio gt 450 dx Leica Biosystems Imaging, Inc. K232202 04/16/2024
sectra digital pathology module (version 3.3) Sectra AB K232208 04/16/2024
access ostase Beckman Coulter K232904 04/15/2024
access nt-probnp Beckman Coulter Inc. K232164 04/12/2024
hcg one step pregnancy test strip otc, hcg one step pregnancy test strip rx, hcg one step pregnancy test midstream otc, hcg one step pregnancy test midstream rx Hangzhou Aichek Medical Technology Co., Ltd. K233624 04/12/2024

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