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

    RAPID IMMUNO-ASSAY SYS

    K Number: K840257 · Decision Apr 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    87

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    Basic Information

    Device Name
    RAPID IMMUNO-ASSAY SYS
    K Number
    K840257
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Applied Polytechnology, Inc.
    Date Received
    January 23, 1984
    Decision Date
    April 19, 1984
    Product Code
    LLG
    Advisory Committee
    Hematology
    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
    LLG Kit, Igg, Platelet Associated

    Similar 510(k) Clearances

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

    GENERAL DIAGNOSTICS PLATELET ANTIBODY

    FDA 510(k)
    FDA Class 2 ·Hematology
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    K843359 URINE TRANSPORT KIT
    K843316 INDOLE SPOT TEST KIT 270-25
    K834264 REVERSE-FLOW SYSTEM