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U.S. Department of Health and Human Services

510(k) Premarket Notification
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31 to 40 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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tandem mobi insulin pump with interoperable technology Tandem Diabetes Care, Inc. K240309 03/21/2024
access ferritin Beckman Coulter, Inc K234052 03/20/2024
pathfast®hs-ctni-ii PHC Corporation K231974 03/20/2024
arx viral transport media collection and transport system ARX Sciences, Inc. K231843 03/19/2024
bd phoenix™ automated microbiology system - gn ciprofloxacin (0.0156–4 µg/ml) Becton, Dickinson and Company K233986 03/15/2024
xprecia prime coagulation system Universal Biosensors Pty Ltd K230802 03/15/2024
deka ace pump system Deka Research and Development K233952 03/13/2024
deka loop Deka Research and Development K234055 03/13/2024
immulite® 2000 br-ma Siemens Healthcare Diagnostics Products Ltd K233946 03/13/2024
nxtag respiratory pathogen panel v2 (nxtag rpp v2) Luminex Molecular Diagnostics, Inc. K231758 03/11/2024

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