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Precision Biologic, Inc.

FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories2
Latest Approval2025-08-25
TypeNumberDevice NameCodeDate
510(k) K251440 CRYOcheck Chromogenic Factor VIII GGP 2025-08-25 View
510(k) K222831 CRYOcheck Factor VIII Deficient Plasma with VWF GJT 2023-09-13 View
510(k) K214002 CRYOcheck Chromogenic Factor IX GGP 2022-12-23 View
510(k) K183440 CRYOcheck FVIII Inhibitor Kit GGP 2019-03-12 View