BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    URINOSCOPY FUNNEL

    K Number: K871671 · Decision May 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    1
    Applicant Total
    9
    Review Days
    22

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    Basic Information

    Device Name
    URINOSCOPY FUNNEL
    K Number
    K871671
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.6160
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Portable Medical Laboratories, Inc.
    Date Received
    April 28, 1987
    Decision Date
    May 20, 1987
    Product Code
    GHO
    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
    GHO Hemocytometer

    Similar 510(k) Clearances

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

    EMATOLOGY DILUENT RESERVOIR CLOSURE

    FDA 510(k)
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    Other Clearances by Portable Medical Laboratories, Inc.

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    K854735 MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.
    K844476 PORTABLE DIAGNOSTIC LABORATORY
    K844475 SPECIMEN COLLECTION & TRANSPORT SYSTEM
    K844442 RAPID DIAGNOSTIC KIT
    K844473 HAND-HELD SLIDE READER