BEUDAMED
    Product Code: GGG FDA class 2 21 CFR 864.6550

    Guaiac Reagent

    Hematology

    Guaiac Reagent (product code GGG) is a chemical reagent used in hematology laboratories to detect the presence of blood or hemoglobin in specimens, based on the peroxidase activity of hemoglobin oxidizing guaiac in the presence of hydrogen peroxide. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. Regulated under 21 CFR 864.6550 in the Hematology specialty (HE), it is eligible for third-party review.

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

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    Basic Information

    Product Code
    GGG
    Device Class
    FDA class 2
    Regulation Number
    864.6550
    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
    K812603 TANARAMA