BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

    K Number: K180607 · Decision Nov 23, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    1
    Applicant Total
    5
    Review Days
    261

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    Basic Information

    Device Name
    Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
    K Number
    K180607
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kronus, Inc.
    Date Received
    March 7, 2018
    Decision Date
    November 23, 2018
    Product Code
    PCG
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PCG 21-Hydroxylase Antibody (21-Ohab)

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