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

    SICKLE CELL TEST KIT

    K Number: K932872 · Decision Aug 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    63

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    Basic Information

    Device Name
    SICKLE CELL TEST KIT
    K Number
    K932872
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7825
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Histo-Med, Inc.
    Date Received
    June 14, 1993
    Decision Date
    August 16, 1993
    Product Code
    JBB
    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
    JBB Solubility, Hemoglobin, Abnormal

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