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SEKISUI Diagnostics, LLC

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest FDA decision2025-04-18
TypeNumberDevice NameCodeDateActions
510(k) K241188 Acucy® Influenza A&B Test with the Acucy® 2 SystemPSZ2025-04-18 View
510(k) K192719 Osom Ultra Plus Flu A&B Test KitPSZ2020-04-03 View
510(k) K182001 Acucy Influenza A&B Test with the Acucy SystemPSZ2018-12-17 View
510(k) K181436 OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestKTN2018-06-22 View
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