BEUDAMED
    Product Code: LET FDA class 2 21 CFR 862.3660

    Fluorescent Immunoassay, Phenobarbital

    Clinical Toxicology

    The Fluorescent Immunoassay for Phenobarbital is a clinical laboratory test designed to measure phenobarbital concentrations in patient blood or urine, enabling therapeutic drug monitoring for patients treated with this anticonvulsant and sedative medication. The device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. It bears product code LET and is governed by 21 CFR 862.3660 under the Clinical Toxicology specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    8
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    6
    Years Active
    10

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    Basic Information

    Product Code
    LET
    Device Class
    FDA class 2
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K901537 MODIFIED OPUS PHENOBARBITAL TEST SYSTEM
    K865000 IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS
    K842592 AMES TDA PHENOBARBITAL TEST
    K830701 STRATUS PHENOBARBITAL FLUOROMETRIC ENZ
    K821408 PHENOBARBITAL FLUORESCENT IMMUNO
    K820188 PHENOBARBITAL ASSAY
    K810994 AMES TDA TM PHENOBARBITAL TEST
    K802255 AMES TDA PHENOBARBITAL TEST