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

    ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.

    K Number: K052694 · Decision Dec 16, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    8
    Review Days
    79

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    Basic Information

    Device Name
    ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
    K Number
    K052694
    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
    September 28, 2005
    Decision Date
    December 16, 2005
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Ind Diagnostic, Inc.

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    K060810 ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC
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