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

    FLAME PHOTOMETRY REAGENTS

    K Number: K803051 · Decision Jan 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    8
    Review Days
    38

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    Basic Information

    Device Name
    FLAME PHOTOMETRY REAGENTS
    K Number
    K803051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Laboratory Products, Inc.
    Date Received
    December 2, 1980
    Decision Date
    January 9, 1981
    Product Code
    JIX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JIX Calibrator, Multi-Analyte Mixture

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    Other Clearances by Laboratory Products, Inc.

    K Number Device Name
    K832588 CIN AGAR
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    K803050 SPRAY, SYNTHETIC SMEAR
    K800180 VARIOUS REAGENTS FOR BLOOD CELL ANALYZER
    K792482 CHEMISTRY ANALYZER REAGENTS
    K792481 CULTURE PLATES & TUBED MEDIA
    K792483 STAINS, COUNTERSTAINS & GEN. PURPOSE