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

    SICKLE-CHEX SOLUBILITY KIT

    K Number: K023656 · Decision Dec 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    17
    Applicant Total
    70
    Review Days
    61

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    Basic Information

    Device Name
    SICKLE-CHEX SOLUBILITY KIT
    K Number
    K023656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7825
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Streck Laboratories, Inc.
    Date Received
    October 30, 2002
    Decision Date
    December 30, 2002
    Product Code
    GHM
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GHM Test, Sickle Cell

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    Other Clearances by Streck Laboratories, Inc.

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    K021922 MODIFICATION TO PARA 5X
    K020469 CAL-CHEX CD PLUS
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    K000115 RETIC CHEX LINEARITY
    Search all 70 clearances from Streck Laboratories, Inc. →