BEUDAMED
    Product Code: JLM FDA class 2 21 CFR 864.7360

    Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase

    Hematology

    This device is an electrophoretic isoenzyme test system used to detect and characterize glucose-6-phosphate dehydrogenase (G6PD) isoenzymes in patient specimens, supporting diagnosis of G6PD deficiency, an X-linked enzyme disorder that predisposes individuals to hemolytic anemia. It is classified as FDA Class 2 and requires 510(k) premarket notification, falling within the Hematology medical specialty under 21 CFR 864.7360. This device is eligible for third-party 510(k) review.

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

    Basic Information

    Product Code
    JLM
    Device Class
    FDA class 2
    Regulation Number
    864.7360
    Medical Specialty
    Hematology
    Review Panel
    HE
    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
    K873625 CHEMELIA ENZYME IMMUNOASSAY FOR (TSH)