BEUDAMED
    Product Code: CJN FDA class 2 21 CFR 862.1020

    Acid Phosphatase, Nitrophenylphosphate

    Clinical Chemistry

    The Acid Phosphatase, Nitrophenylphosphate test system (product code CJN) is an in-vitro diagnostic device used in clinical chemistry to measure acid phosphatase activity in serum using para-nitrophenyl phosphate as a chromogenic substrate under acidic conditions, historically used in the evaluation of prostate disease and bone disorders. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1020 in the Clinical Chemistry medical specialty.

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

    Research product code CJN in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    CJN
    Device Class
    FDA class 2
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K781489 ACID PHOSPHATASE DIAG. KIT