BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CRYOcheck Chromogenic Factor VIII

    K Number: K251440 · Decision Aug 25, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    7
    Review Days
    108

    Basic Information

    Device Name
    CRYOcheck Chromogenic Factor VIII
    K Number
    K251440
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Biologic, Inc.
    Date Received
    May 9, 2025
    Decision Date
    August 25, 2025
    Product Code
    GGP
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GGP Test, Qualitative And Quantitative Factor Deficiency

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    Other Clearances by Precision Biologic, Inc.

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