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

    MONITORX LASERX THEOPHYLLINE REAGENT SET

    K Number: K870277 · Decision Feb 18, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    73
    Review Days
    22

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    Basic Information

    Device Name
    MONITORX LASERX THEOPHYLLINE REAGENT SET
    K Number
    K870277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    American Monitor Corp.
    Date Received
    January 27, 1987
    Decision Date
    February 18, 1987
    Product Code
    LGS
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LGS Fluorescence Polarization Immunoassay, Theophylline

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    Other Clearances by American Monitor Corp.

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    K895423 ACCESS CHEMISTRY ANALYZER
    K893137 EXCEL (TM) CHEMISTRY ANALYZER
    K892331 ENZYMATIC UREA NITROGEN REAGENT SET
    K893479 CHOLESTEROL REAGENT SET
    K892002 NEOCHROME(R) III GLUCOSE
    K890312 GAMMA-GLUTAMYLTRANSFERASE
    K890034 PHOTOMETRIC METHOD, IRON (NON-HEME) (75JIY)
    Search all 73 clearances from American Monitor Corp. →