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

    G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE

    K Number: K024006 · Decision Mar 31, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    4
    Applicant Total
    74
    Review Days
    117

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    Basic Information

    Device Name
    G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
    K Number
    K024006
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7360
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pointe Scientific, Inc.,
    Date Received
    December 4, 2002
    Decision Date
    March 31, 2003
    Product Code
    JBF
    Advisory Committee
    Hematology
    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
    JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening

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