BEUDAMED
    Product Code: CJD FDA class 2 21 CFR 862.1070

    Nitrosalicylate Reduction, Amylase

    Clinical Chemistry

    The Nitrosalicylate Reduction, Amylase test system (product code CJD) is an in-vitro diagnostic device used in clinical chemistry to measure amylase activity in serum or urine using a method based on nitrosalicylate reduction as an indicator of starch hydrolysis, supporting the evaluation of pancreatic and salivary function. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1070 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    CJD
    Device Class
    FDA class 2
    Regulation Number
    862.1070
    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
    K915704 AMYLASE (KINETIC) REAGENT SET