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

    B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)

    K Number: K971935 · Decision Oct 1, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    127

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    Basic Information

    Device Name
    B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)
    K Number
    K971935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7140
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B & D Corp.
    Date Received
    May 27, 1997
    Decision Date
    October 1, 1997
    Product Code
    JBP
    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
    JBP Activated Whole Blood Clotting Time

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