BEUDAMED
    Product Code: IDT FDA class 1 21 CFR 864.3010

    Apparatus, Melting Point, Paraffin

    Pathology

    A paraffin melting point apparatus is a laboratory instrument used in histopathology to determine or control the precise melting point of paraffin wax, ensuring appropriate consistency and temperature for tissue embedding procedures. It is regulated as an FDA Class 1 device, the lowest risk category, subject only to general controls without requiring premarket notification. The product code is IDT, regulated under 21 CFR 864.3010, in the Pathology medical specialty. This device is exempt from GMP requirements.

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    510(k)s
    0
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    IDT
    Device Class
    FDA class 1
    Regulation Number
    864.3010
    Medical Specialty
    Pathology
    Review Panel
    PA
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.