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

    PT PRO-CLOT

    K Number: K874373 · Decision Jan 5, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    71

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    Basic Information

    Device Name
    PT PRO-CLOT
    K Number
    K874373
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Probe-Tek, Inc.
    Date Received
    October 26, 1987
    Decision Date
    January 5, 1988
    Product Code
    JBR
    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
    JBR Test, Heparin Neutralization

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    Other Clearances by Probe-Tek, Inc.

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