BEUDAMED
    Product Code: LTC FDA class 3

    Hyaline Membrane Disease Assay

    Unknown

    The Hyaline Membrane Disease Assay is a diagnostic device used to assess fetal lung maturity by measuring components in amniotic fluid or related specimens that indicate the risk of hyaline membrane disease (respiratory distress syndrome) in the newborn, typically used in the management of preterm labor. It is classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA) given the critical clinical consequences of inaccurate assessment of neonatal lung maturity. The product code is LTC; no regulation number or specific medical specialty code is on file. No special flags apply to this device.

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

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    Basic Information

    Product Code
    LTC
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    CH
    Submission Type
    3

    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
    K844637 WHITESIDE ACRYLIC CEMENT SPACER SLEEVE