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

    HCG STAT PAK ULTRA-FAST

    K Number: K011550 · Decision Aug 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    6
    Review Days
    88

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    Basic Information

    Device Name
    HCG STAT PAK ULTRA-FAST
    K Number
    K011550
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Chembio Diagnostic Systems, Inc.
    Date Received
    May 18, 2001
    Decision Date
    August 14, 2001
    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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