BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SPECIMEN COLLECTION & TRANSPORT SYSTEM

    K Number: K844475 · Decision Feb 6, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    9
    Review Days
    79

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    Basic Information

    Device Name
    SPECIMEN COLLECTION & TRANSPORT SYSTEM
    K Number
    K844475
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Portable Medical Laboratories, Inc.
    Date Received
    November 19, 1984
    Decision Date
    February 6, 1985
    Product Code
    FMF
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FMF Syringe, Piston

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    K844473 HAND-HELD SLIDE READER