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

    ACRO HCG Pregnancy Rapid Test

    K Number: K172512 · Decision Feb 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    2
    Review Days
    165

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    Basic Information

    Device Name
    ACRO HCG Pregnancy Rapid Test
    K Number
    K172512
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acro Biotech, Inc.
    Date Received
    August 21, 2017
    Decision Date
    February 2, 2018
    Product Code
    LCX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by Acro Biotech, Inc.

    K Number Device Name
    K180771 Acro HCG Pregnancy Rapid Test