BEUDAMED
    Product Code: PSM FDA class 1 21 CFR 862.2800

    Refractometer For Donor Testing

    Clinical Chemistry

    The Refractometer for Donor Testing is a clinical chemistry instrument used for total protein testing of plasma donors to determine donor eligibility for plasma donation, employing refractometry to measure protein concentration. It is classified as FDA Class 1 under 21 CFR 862.2800 in the Clinical Chemistry specialty, subject only to general controls, and exempt from 510(k) premarket notification requirements. Product code PSM; not an implant and not life-sustaining.

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

    Basic Information

    Product Code
    PSM
    Device Class
    FDA class 1
    Regulation Number
    862.2800
    Medical Specialty
    Clinical Chemistry
    Review Panel
    CH
    Submission Type
    4

    Device Characteristics

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

    Definition

    For total protein testing of plasma donors to determine eligibility.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.