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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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