FDA 510(k) Applications Submitted by Accriva Diagnostics, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K202101 07/29/2020 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, Lev Accriva Diagnostics, Inc.
K193041 10/31/2019 Hemochron Signature Elite Accriva Diagnostics, Inc.
K223352 11/02/2022 Tenderfoot Accriva Diagnostics, Inc.


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