BEUDAMED
    Product Code: DLC FDA class 1 21 CFR 862.2270

    Atomizer, Tlc

    Clinical Chemistry

    The Atomizer for Thin Layer Chromatography is a laboratory instrument used to apply reagent sprays uniformly onto TLC plates for the visualization of separated compounds in chromatographic analysis. It is a Class 1 device subject to general controls only and does not require premarket notification. The product code is DLC, regulated under 21 CFR 862.2270, within the Clinical Chemistry specialty. It is GMP exempt, indicating reduced manufacturing quality system requirements apply.

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

    Product Code
    DLC
    Device Class
    FDA class 1
    Regulation Number
    862.2270
    Medical Specialty
    Clinical Chemistry
    Review Panel
    TX
    Submission Type
    4

    Device Characteristics

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