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

    HEMOGLOBIN SCREENING DEVICE

    K Number: K882101 · Decision Jul 1, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    1
    Applicant Total
    9
    Review Days
    51

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    Basic Information

    Device Name
    HEMOGLOBIN SCREENING DEVICE
    K Number
    K882101
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.9320
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Portable Medical Laboratories, Inc.
    Date Received
    May 11, 1988
    Decision Date
    July 1, 1988
    Product Code
    KSL
    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
    KSL Solution, Copper Sulfate For Specific Gravity Determinations

    Similar 510(k) Clearances

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

    COPPER SULFATE SOLUTION SP. GR.1.055

    FDA 510(k)
    FDA Class 1 ·Hematology
    View all

    Other Clearances by Portable Medical Laboratories, Inc.

    K Number Device Name
    K874190 CELL COUNTING GRID GRATICULE
    K871671 URINOSCOPY FUNNEL
    K864049 MCARTHUR MICROSCOPE, STANDARD METAL VERSION
    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