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ACON Laboratories, Inc.

FDA 510(k) & PMA Approved 器械 — 16 products

器械总数16
类别0
最新FDA决定
类型编号器械名称代码日期操作
510(k) K261212 Flowflex Plus RSV + 流感A/B + COVID快速测试SCA2026-07-10 查看
510(k) K251697 Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripGTY2025-11-26 查看
510(k) K251749 Flowflex Plus RSV + Flu A/B + COVID Home TestSCA2025-10-22 查看
510(k) K250085 On Call® Sure GK 血糖 & 酮体监测系统；On Call® Sure Sync GK 血糖 & 酮体监测系统NBW2025-10-10 查看
510(k) K250377 Flowflex Plus COVID-19 + Flu A/B Home TestSCA2025-05-10 查看
510(k) K232715 Distinct® 数字妊娠测试LCX2024-05-31 查看
510(k) K233373 Flowflex® Plus COVID-19 Home TestQYT2024-04-19 查看
510(k) K230828 Flowflex COVID-19 Antigen Home TestQYT2023-11-09 查看
510(k) K193318 Distinct® 早期检测妊娠测试LCX2020-08-20 查看
510(k) K192175 On Call Express II 血糖监测系统NBW2019-10-17 查看
510(k) K191038 On Call Express 语音血糖监测系统NBW2019-06-12 查看
510(k) K181527 On Call Sure 血糖监测系统，On Call Sure Sync 血糖监测系统NBW2018-10-03 查看
510(k) K180504 Mission 脂质面板监测系统CHH2018-03-28 查看
510(k) K180196 On Call Express 移动血糖监测系统NBW2018-03-07 查看
510(k) K163406 Mission 胆固醇监测系统，Mission 胆固醇专业监测系统CHH2017-07-11 查看
510(k) K170587 On Call 酮体试纸条，Healthy Me 酮体试纸条JIN2017-07-06 查看
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