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

    PSI ALBUMIN REAGENT

    K Number: K822471 · Decision Sep 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    74
    Review Days
    28

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    Basic Information

    Device Name
    PSI ALBUMIN REAGENT
    K Number
    K822471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pointe Scientific, Inc.,
    Date Received
    August 17, 1982
    Decision Date
    September 14, 1982
    Product Code
    CIX
    Advisory Committee
    Clinical Chemistry
    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
    CIX Bromcresol Green Dye-Binding, Albumin

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    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., →