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

    FPR THEOPHYLLINE KIT

    K Number: K894529 · Decision Sep 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    16
    Review Days
    57

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    Basic Information

    Device Name
    FPR THEOPHYLLINE KIT
    K Number
    K894529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Colony Laboratories, Inc.
    Date Received
    July 20, 1989
    Decision Date
    September 15, 1989
    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 Colony Laboratories, Inc.

    K Number Device Name
    K894524 FPR GENTAMICIN CALIBRATOR KIT
    K894517 FPR AMIKACIN KIT
    K894523 FPR GENTAMICIN KIT
    K894518 FPR AMIKACIN CALIBRATOR KIT
    K894521 FPR DIGOXIN KIT
    K894527 FPR PHENYTOIN KIT
    K894528 FPR PHENYTOIN CALIBRATOR KIT
    K894522 FPR DIGOXIN CALIBRATOR KIT
    K894530 FPR THEOPHYLLINE CALIBRATOR KIT
    K894532 FPR TOBRAMYCIN CALIBRATOR KIT
    Search all 16 clearances from Colony Laboratories, Inc. →