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

    HEMOHLOBIN A2 CONTROL-LYOPHILIZED

    K Number: K801410 · Decision Jul 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    12
    Applicant Total
    44
    Review Days
    35

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    Basic Information

    Device Name
    HEMOHLOBIN A2 CONTROL-LYOPHILIZED
    K Number
    K801410
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7400
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Isolab, Inc.
    Date Received
    June 16, 1980
    Decision Date
    July 21, 1980
    Product Code
    JPD
    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
    JPD Hemoglobin A2 Quantitation

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