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

    HEMOGLOBIN

    K Number: K851432 · Decision Jul 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    74
    Review Days
    93

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    HEMOGLOBIN
    K Number
    K851432
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pointe Scientific, Inc.,
    Date Received
    April 10, 1985
    Decision Date
    July 12, 1985
    Product Code
    KHG
    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
    KHG Whole Blood Hemoglobin Determination

    Similar 510(k) Clearances

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

    AnemoCheck Home

    FDA 510(k)
    FDA Class 2 ·Hematology

    AnemoCheck

    FDA 510(k)
    FDA Class 2 ·Hematology

    ANEMIAPRO SELF-SCREENER

    FDA 510(k)
    FDA Class 2 ·Hematology

    STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090

    FDA 510(k)
    FDA Class 2 ·Hematology

    CARESIDE HEMOGLOBIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEMOSITE TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by Pointe Scientific, Inc.,

    K Number Device Name
    K070757 MICROPROTEIN REAGENT SET
    K062118 POINTE 360
    K070251 CARBON DIOXIDE LIQUID STABLE REAGENT
    K070207 MULTI-ANALYTE CHEMISTRY CALIBRATOR
    K070504 AMMONIA/ALCOHOL CONTROL SET
    K061377 APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
    K051646 ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
    K040391 TOTAL BILIRUBIN REAGENT SET
    K031539 HEMOGLOBIN A1C REAGENT SET
    K023860 MICROALBUMIN REAGENT SET AND CALIBRATORS
    Search all 74 clearances from Pointe Scientific, Inc., →