FDA 510(k)

CRYOcheck Chromogenic Factor VIII

K-Number: K251440 · 2025-08-25

Decision Date2025-08-25

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CRYOcheck Chromogenic Factor VIII is a medical device manufactured by Precision Biologic, Inc.. It received FDA 510(k) clearance on 2025-08-25 under approval number K251440. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOcheck Chromogenic Factor VIII?

CRYOcheck Chromogenic Factor VIII is a medical device that received FDA 510(k) clearance on 2025-08-25. It is manufactured by Precision Biologic, Inc.. The 510(k) number is K251440.

When was CRYOcheck Chromogenic Factor VIII approved by the FDA?

CRYOcheck Chromogenic Factor VIII received FDA 510(k) clearance on 2025-08-25, under approval number K251440.

What company makes CRYOcheck Chromogenic Factor VIII?

CRYOcheck Chromogenic Factor VIII is manufactured by Precision Biologic, Inc..

What is the FDA product code for CRYOcheck Chromogenic Factor VIII?

The FDA product code for CRYOcheck Chromogenic Factor VIII is GGP.

Other Devices by Precision Biologic, Inc.

K183440CRYOcheck FVIII Inhibitor Kit K214002CRYOcheck Chromogenic Factor IX K222831CRYOcheck Factor VIII Deficient Plasma with VWF

Related Devices (Code: GGP)

K181525INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbH K183440CRYOcheck FVIII Inhibitor KitPrecision Biologic, Inc. K200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO K193204Cryocheck Chromogenic Factor VIIIPrecision Biologic K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc. K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.