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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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