FDA 510(k)

CRYOcheck FVIII Inhibitor Kit

K-Number: K183440 · 2019-03-12

Decision Date2019-03-12

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CRYOcheck FVIII Inhibitor Kit is a medical device manufactured by Precision Biologic, Inc.. It received FDA 510(k) clearance on 2019-03-12 under approval number K183440. 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 FVIII Inhibitor Kit?

CRYOcheck FVIII Inhibitor Kit is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Precision Biologic, Inc.. The 510(k) number is K183440.

When was CRYOcheck FVIII Inhibitor Kit approved by the FDA?

CRYOcheck FVIII Inhibitor Kit received FDA 510(k) clearance on 2019-03-12, under approval number K183440.

What company makes CRYOcheck FVIII Inhibitor Kit?

CRYOcheck FVIII Inhibitor Kit is manufactured by Precision Biologic, Inc..

What is the FDA product code for CRYOcheck FVIII Inhibitor Kit?

The FDA product code for CRYOcheck FVIII Inhibitor Kit is GGP.

Other Devices by Precision Biologic, Inc.

K214002CRYOcheck Chromogenic Factor IX K222831CRYOcheck Factor VIII Deficient Plasma with VWF K251440CRYOcheck Chromogenic Factor VIII

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K181525INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbH 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 K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company

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.