FDA 510(k) Applications Submitted by Karen Black

FDA 510(k) Number Submission Date Device Name Applicant
K222831 09/19/2022 CRYOcheck Factor VIII Deficient Plasma with VWF Precision BioLogic Inc.
K193204 11/20/2019 Cryocheck Chromogenic Factor VIII Precision BioLogic
K214002 12/21/2021 CRYOcheck Chromogenic Factor IX Precision BioLogic Inc.
K193556 12/23/2019 Cryocheck Hex LA Precision BioLogic
K183440 12/12/2018 CRYOcheck FVIII Inhibitor Kit Precision BioLogic Inc.


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