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U.S. Department of Health and Human Services

510(k) Premarket Notification
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91 to 100 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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savanna hsv 1+2/vzv assay, savanna hsv 1+2/vzv control set, savanna instrument Quidel Corporation K232286 12/20/2023
access hstni Beckman Coulter Inc K222881 12/18/2023
hp detect™ stool antigen elisa Biomerica, Inc. K232892 12/15/2023
septicyte rapid Immunexpress, Inc K232095 12/15/2023
alltest multi-drug rapid test cup; alltest multi-drug rapid test panel; alltest multi-drug rapid test cup rx; alltest multi-drug rapid test panel rx Hangzhou AllTest Biotech Co.,Ltd K233019 12/13/2023
dochek® multi-drug urine test cup rx, dochek® multi-drug urine test cup Guangzhou Decheng Biotechnology Co., Ltd. K232659 12/13/2023
hemosil chromogenic factor ix Instrumentation Laboratory Company K230852 12/13/2023
n antisera to human immunoglobulins (igg, iga, and igm) Siemens Healthcare Diagnostics Products GmbH K233663 12/13/2023
sofia 2 sars antigen+ fia; sofia 2 sars antigen+ fia control swab set Quidel Corporation K233688 12/13/2023
insulia bolus companion Voluntis SA. K232451 12/12/2023

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