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

    ALBUMIN REAGENT

    K Number: K021636 · Decision Jul 17, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    17
    Applicant Total
    21
    Review Days
    61

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    Basic Information

    Device Name
    ALBUMIN REAGENT
    K Number
    K021636
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intersect Systems, Inc.
    Date Received
    May 17, 2002
    Decision Date
    July 17, 2002
    Product Code
    CJW
    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
    CJW Bromcresol Purple Dye-Binding, Albumin

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    Other Clearances by Intersect Systems, Inc.

    K Number Device Name
    K011972 DIRECT BILIRUBIN REAGENT
    K011692 HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
    K003892 TOTAL BILIRUBIN REAGENT
    K983937 DUAL VIAL CREATININE REAGENT
    K974833 CK-NAC REAGENT
    K941807 INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT
    K932888 INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
    K934039 INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
    K932267 ENZYMATIC CO2 REAGENT, MODIFICATION
    K913225 URINE/CSF MICROPROTEIN REAGENT
    Search all 21 clearances from Intersect Systems, Inc. →