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

    HEMOSITE TEST SYSTEM

    K Number: K973649 · Decision Aug 31, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    38
    Applicant Total
    7
    Review Days
    340

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    Basic Information

    Device Name
    HEMOSITE TEST SYSTEM
    K Number
    K973649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7500
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gds Technology, LLC
    Date Received
    September 25, 1997
    Decision Date
    August 31, 1998
    Product Code
    KHG
    Advisory Committee
    Hematology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHG Whole Blood Hemoglobin Determination

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    Other Clearances by Gds Technology, LLC

    K Number Device Name
    K994073 HEMOSITE TEST SYSTEM
    K992132 CHOLESITE TEST SYSTEM
    K971145 GLUCOSITE TEST SYSTEM
    K911801 KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
    K882038 GDS ENZYMATIC SALICYLATE REAGENT
    K880829 GDS ENZYMATIC ACETAMINOPHEN REAGENT