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

    ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400

    K Number: K170901 · Decision Apr 13, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    4
    Review Days
    382

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    Basic Information

    Device Name
    ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
    K Number
    K170901
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Biosystems S.A.
    Date Received
    March 27, 2017
    Decision Date
    April 13, 2018
    Product Code
    CIX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CIX Bromcresol Green Dye-Binding, Albumin

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    Other Clearances by Biosystems S.A.

    K Number Device Name
    K192730 CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
    K190495 Transferrin
    K182474 alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL