BEUDAMED
    Product Code: OSL FDA class 2 21 CFR 864.6550

    Control, Fecal Occult Blood

    Hematology

    The Control, Fecal Occult Blood (product code OSL) is a quality control product consisting of negative and positive controls used to verify the performance of fecal occult blood test devices. These controls ensure that fecal occult blood testing systems are functioning correctly and producing reliable results. As an FDA Class 2 device under regulation 864.6550, it requires 510(k) premarket clearance and falls within the Hematology specialty. The device is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    OSL
    Device Class
    FDA class 2
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Review Panel
    HE
    Submission Type
    4

    Device Characteristics

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

    Definition

    Fecal occult blood controls (Negative and positive) are used to verify the performance of the fecal occult blood test devices.

    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
    K101831 ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.