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FDA 510(k)

CRYOcheck Chromogenic Factor VIII

K-Number: K251440 · 2025-08-25

ApplicantPrecision Biologic, Inc.
Decision Date2025-08-25
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYOcheck Chromogenic Factor VIII 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 2025-08-25 under 510(k) 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. The listed applicant is Precision Biologic, Inc.. The 510(k) number is K251440.

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

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

Who is the listed applicant for CRYOcheck Chromogenic Factor VIII?

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 VIII?

The FDA product code for CRYOcheck Chromogenic Factor VIII 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.

K222831CRYOcheck Factor VIII Deficient Plasma with VWFK214002CRYOcheck Chromogenic Factor IXK193556Cryocheck 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.

K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL 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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