BEUDAMED
    Product Code: NGK FDA class 2 21 CFR 864.6550

    Test, Occult Blood, Over The Counter

    Hematology

    The Test, Occult Blood, Over The Counter (product code NGK) is an in vitro diagnostic test for consumer home use that detects hidden (occult) blood in stool specimens, used as a colorectal cancer screening tool or to identify gastrointestinal bleeding. It is classified as an FDA Class 2 device within the Hematology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NGK
    Device Class
    FDA class 2
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Review Panel
    TX
    Submission Type
    1

    Device Characteristics

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