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

    PHOSPHORUS IL

    K Number: K820832 · Decision Apr 15, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    73
    Review Days
    20

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    Basic Information

    Device Name
    PHOSPHORUS IL
    K Number
    K820832
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1520
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    American Monitor Corp.
    Date Received
    March 26, 1982
    Decision Date
    April 15, 1982
    Product Code
    CED
    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
    CED 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

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    Other Clearances by American Monitor Corp.

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    K893137 EXCEL (TM) CHEMISTRY ANALYZER
    K892331 ENZYMATIC UREA NITROGEN REAGENT SET
    K893479 CHOLESTEROL REAGENT SET
    K892002 NEOCHROME(R) III GLUCOSE
    K890312 GAMMA-GLUTAMYLTRANSFERASE
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    Search all 73 clearances from American Monitor Corp. →