BEUDAMED
    Product Code: CDR FDA class 1 21 CFR 862.1730

    1-Nitroso-2-Naphthol (Fluorometric), Free Tyrosine

    Clinical Chemistry

    The 1-Nitroso-2-Naphthol Fluorometric Free Tyrosine Test is a clinical chemistry device that measures free tyrosine levels in biological specimens using fluorometric detection of the colored complex formed between tyrosine and 1-nitroso-2-naphthol, used in the evaluation of phenylketonuria and other amino acid metabolism disorders. It is classified as FDA Class 1 (lowest risk). The product code is CDR, regulated under 21 CFR 862.1730, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    CDR
    Device Class
    FDA class 1
    Regulation Number
    862.1730
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K970093 TYROSINE 50-HOUR REAGENT KIT

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.