FDA 510(k)

CRYOcheck Chromogenic Factor IX

K-Number: K214002 · 2022-12-23

Decision Date2022-12-23

Product CodeGGP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CRYOcheck Chromogenic Factor IX is a medical device manufactured by Precision Biologic, Inc.. It received FDA 510(k) clearance on 2022-12-23 under approval number K214002. 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 IX?

CRYOcheck Chromogenic Factor IX is a medical device that received FDA 510(k) clearance on 2022-12-23. It is manufactured by Precision Biologic, Inc.. The 510(k) number is K214002.

When was CRYOcheck Chromogenic Factor IX approved by the FDA?

CRYOcheck Chromogenic Factor IX received FDA 510(k) clearance on 2022-12-23, under approval number K214002.

What company makes CRYOcheck Chromogenic Factor IX?

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

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

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

Other Devices by Precision Biologic, Inc.

K183440CRYOcheck FVIII Inhibitor Kit K222831CRYOcheck Factor VIII Deficient Plasma with VWF K251440CRYOcheck Chromogenic Factor VIII

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 K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company

Official Source

View on FDA Database →

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