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U.S. Department of Health and Human Services

510(k) Premarket Notification
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51 to 60 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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contour® plus blue blood glucose monitoring system Ascensia Diabetes Care K231679 02/23/2024
flc kappa, flc lambda,flc control level 1, flc control level 2 Sebia K231601 02/23/2024
multi-drug urine test cup, multi-drug urine test dip card, accurature multi-drug urine test cup, accurature multi-drug urine test dip card Shanghai Accurature Diagnostics Co., Ltd. K232228 02/23/2024
statstrip glucose hospital meter system Nova Biomedical Corporation K232075 02/23/2024
vivatmo pro Bosch Healthcare Solutions GmbH K233775 02/22/2024
online tdm methotrexate Roche Diagnostics Operations K233454 02/20/2024
access ck-mb Beckman Coulter, Inc K234005 02/16/2024
pbc separator with selux ast system Selux Diagnostics, Inc K223493 02/15/2024
access shbg Beckman Coulter Inc. K233480 02/08/2024
concentriq dx Proscia, Inc. K230839 02/08/2024

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