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FDA 510(k)

CRYOcheck FVIII Inhibitor Kit

K-Number: K183440 · 2019-03-12

ApplicantPrecision Biologic, Inc.
Decision Date2019-03-12
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CRYOcheck FVIII Inhibitor Kit 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 2019-03-12 under 510(k) 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. The listed applicant is Precision Biologic, Inc.. The 510(k) number is K183440.

When did CRYOcheck FVIII Inhibitor Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for CRYOcheck FVIII Inhibitor Kit?

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 FVIII Inhibitor Kit?

The FDA product code for CRYOcheck FVIII Inhibitor Kit 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 VWFK214002CRYOcheck Chromogenic Factor IXK193556Cryocheck Hex LAK193204Cryocheck Chromogenic Factor VIII

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 GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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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