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U.S. Department of Health and Human Services

510(k) Premarket Notification
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131 to 140 of 500 Results *
Decision Date From: 8/1/2003 Decision Date To: 04/23/2024 In Vitro Products: Yes
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safety butterfly type blood collection needle, butterfly type blood collection needle, pen type blood collection needle, safety pen Jiangsu Rongye Technology Co., Ltd. K213146 10/27/2023
alltest fentanyl urine test cassette Hangzhou AllTest Biotech Co.,Ltd K233417 10/26/2023
vitek 2 ast-streptococcus penicillin (<=0.06 - =>8 µg/ml), vitek 2 streptococcus penicillin (<=0.06 - >=8 µg/ml), vitek 2 streptococcus penicillin bioMerieux, Inc K232201 10/23/2023
xpert xpress mvp; genexpert xpress system Cepheid K231381 10/19/2023
omnipod 5 ace pump Insulet Corporation K231826 10/18/2023
smartbolus calculator Insulet Corporation K231824 10/18/2023
macro & micro-test hcg pregnancy test midstream Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. K230741 10/13/2023
xpert® xpress cov-2 plus Cepheid® K230440 10/13/2023
id now influenza a & b 2 Abbott Diagnostics Scarborough, Inc. K232775 10/10/2023
thermo scientific oxoid sulbactam/durlobactam disc (10/10 µg) sud20 Oxoid Limited (Part of Thermo Fisher Scientific) K232276 10/06/2023

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