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

    PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT

    K Number: K863625 · Decision Nov 10, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    11
    Applicant Total
    19
    Review Days
    54

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    Basic Information

    Device Name
    PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT
    K Number
    K863625
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Windsor Laboratories, Inc.
    Date Received
    September 17, 1986
    Decision Date
    November 10, 1986
    Product Code
    LGQ
    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
    LGQ Fluorescence Polarization Immunoassay, Phenobarbital

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    Other Clearances by Windsor Laboratories, Inc.

    K Number Device Name
    K873281 CARBAMAZEPINE (FPIA) CALIBRATOR KIT
    K873282 CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY
    K871486 (FPIA) ASSAY BUFFER
    K870389 DIGOXIN (FPIA) CALIBRATOR KIT
    K870390 PHENOBARBITAL (FPIA) CALIBRATOR KIT
    K864333 DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY
    K863244 AMIKACIN (FPIA) CALIBRATOR KIT
    K862248 AMIKACIN KIT (FPIA)
    K861770 PHENYTOIN (FPIA) CALIBRATOR KIT
    K861768 THEOPHYLLINE (FPIA) CALIBRATOR KIT
    Search all 19 clearances from Windsor Laboratories, Inc. →