BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CASSETTE/URINE HCG

    K Number: K023638 · Decision Jan 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    8
    Review Days
    65

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    Basic Information

    Device Name
    CASSETTE/URINE HCG
    K Number
    K023638
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ind Diagnostic, Inc.
    Date Received
    October 30, 2002
    Decision Date
    January 3, 2003
    Product Code
    LCX
    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
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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    Other Clearances by Ind Diagnostic, Inc.

    K Number Device Name
    K103037 IND URINARY TRACT INFECTION (UTI) TEST STRIPS
    K100031 IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
    K063390 URINE CHEMISTRY ANALYZER UR-50
    K060810 ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
    K052694 ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
    K052662 ONE STEP FSH MENOPAUSAL TEST
    K050741 IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT