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

    RH CONTROL

    K Number: K801425 · Decision Jul 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    11
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    RH CONTROL
    K Number
    K801425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.9650
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    North American Biologicals, Inc.
    Date Received
    June 17, 1980
    Decision Date
    July 14, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KSF), ordered by most recent decision date.

    AVI-D CONTROL

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    RST-SERIES CONTROL

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    ORTHO ANTISERA CONTROL

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    RH-HR NEGATIVE CONTROL REAGENT

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    TEST CELLS

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    Other Clearances by North American Biologicals, Inc.

    K Number Device Name
    K820301 PLASMA POOLER HEAT SEALER
    K801219 PLASMAPOOLER
    K781895 BLOOD GROUP SUBSTANCE B
    K781862 BLOOD GROUP SUBSTANCE A
    K781896 BLOOD GROUP SUBSTANCE A,B