BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    DS30 HCY HOMOCYSTEINE ASSAY KIT

    K Number: K982003 · Decision Feb 11, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    28
    Applicant Total
    7
    Review Days
    248

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    Basic Information

    Device Name
    DS30 HCY HOMOCYSTEINE ASSAY KIT
    K Number
    K982003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1377
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Drew Scientific , Ltd.
    Date Received
    June 8, 1998
    Decision Date
    February 11, 1999
    Product Code
    LPS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LPS Urinary Homocystine (Nonquantitative) Test System

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