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Accriva Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest FDA decision2023-03-02
TypeNumberDevice NameCodeDateActions
510(k) K223352 TenderfootFMK2023-03-02 View
510(k) K202101 GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2JPA2021-12-29 View
510(k) K193041 Hemochron Signature EliteJPA2019-11-22 View
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