BEUDAMED
    Product Code: LOQ FDA class 2 21 CFR 866.6010

    Device, General Purpose, Hematology

    Immunology

    Device, General Purpose, Hematology is a broad-category hematology device used for general laboratory procedures supporting blood analysis, including instruments or reagents used in blood cell identification, immunological testing, or other hematological assays not fitting a more specific classification. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LOQ, regulated under 21 CFR 866.6010, within the Immunology medical specialty. This device is eligible for third-party 510(k) review.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LOQ
    Device Class
    FDA class 2
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    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
    K981592 ACS:CENTAUR AFP

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.