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FDA 510(k)

CRYOcheck Chromogenic Factor IX

K-Number: K214002 · 2022-12-23

ApplicantPrecision Biologic, Inc.
Decision Date2022-12-23
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYOcheck Chromogenic Factor IX is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic, Inc.. It received FDA 510(k) clearance on 2022-12-23 under 510(k) 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. The listed applicant is Precision Biologic, Inc.. The 510(k) number is K214002.

When did CRYOcheck Chromogenic Factor IX receive FDA 510(k) clearance?

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

Who is the listed applicant for CRYOcheck Chromogenic Factor IX?

The FDA 510(k) record lists Precision Biologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Precision Biologic, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251440CRYOcheck Chromogenic Factor VIIIK222831CRYOcheck Factor VIII Deficient Plasma with VWFK193556Cryocheck Hex LAK193204Cryocheck Chromogenic Factor VIIIK183440CRYOcheck FVIII Inhibitor Kit

Related Devices (Code: GGP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK193204Cryocheck Chromogenic Factor VIIIPrecision Biologic

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.

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