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

    RH-HR NEGATIVE CONTROL REAGENT

    K Number: K800239 · Decision Feb 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    RH-HR NEGATIVE CONTROL REAGENT
    K Number
    K800239
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9650
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Gotham Biologics, Inc.
    Date Received
    February 5, 1980
    Decision Date
    February 21, 1980
    Product Code
    KSF
    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
    KSF Kit, Quality Control For Blood Banking Reagents

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