FDA 510(k)

CRYOcheck Factor VIII Deficient Plasma with VWF

K-Number: K222831 · 2023-09-13

Decision Date2023-09-13

Product CodeGJT

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CRYOcheck Factor VIII Deficient Plasma with VWF is a medical device manufactured by Precision Biologic, Inc.. It received FDA 510(k) clearance on 2023-09-13 under approval number K222831. The device is classified under product code GJT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYOcheck Factor VIII Deficient Plasma with VWF?

CRYOcheck Factor VIII Deficient Plasma with VWF is a medical device that received FDA 510(k) clearance on 2023-09-13. It is manufactured by Precision Biologic, Inc.. The 510(k) number is K222831.

When was CRYOcheck Factor VIII Deficient Plasma with VWF approved by the FDA?

CRYOcheck Factor VIII Deficient Plasma with VWF received FDA 510(k) clearance on 2023-09-13, under approval number K222831.

What company makes CRYOcheck Factor VIII Deficient Plasma with VWF?

CRYOcheck Factor VIII Deficient Plasma with VWF is manufactured by Precision Biologic, Inc..

What is the FDA product code for CRYOcheck Factor VIII Deficient Plasma with VWF?

The FDA product code for CRYOcheck Factor VIII Deficient Plasma with VWF is GJT.

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Other Devices by Precision Biologic, Inc.

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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.