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    FDA 510(k) FDA class 2 Substantially Equivalent 🇪🇸 Spain

    Transferrin

    K Number: K190495 · Decision Mar 16, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    47
    Applicant Total
    4
    Review Days
    382

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    Basic Information

    Device Name
    Transferrin
    K Number
    K190495
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5880
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biosystems S.A.
    Date Received
    February 28, 2019
    Decision Date
    March 16, 2020
    Product Code
    DDG
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DDG Transferrin, Antigen, Antiserum, Control

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    Other Clearances by Biosystems S.A.

    K Number Device Name
    K192730 CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
    K182474 alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
    K170901 ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400