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

    Hemosure Accu-Reader A100

    K Number: K200754 · Decision Jun 2, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    5
    Applicant Total
    14
    Review Days
    801

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    Basic Information

    Device Name
    Hemosure Accu-Reader A100
    K Number
    K200754
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W.H.P.M., Inc.
    Date Received
    March 23, 2020
    Decision Date
    June 2, 2022
    Product Code
    OOX
    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
    OOX Automated Occult Blood Analyzer

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