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

    HEMOCHRON(R) HEPARIN RESPONSE TEST

    K Number: K904003 · Decision Nov 29, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    45
    Applicant Total
    12
    Review Days
    92

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    Basic Information

    Device Name
    HEMOCHRON(R) HEPARIN RESPONSE TEST
    K Number
    K904003
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7525
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Intensive Technology, Inc.
    Date Received
    August 29, 1990
    Decision Date
    November 29, 1990
    Product Code
    KFF
    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
    KFF Assay, Heparin

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    Other Clearances by Intensive Technology, Inc.

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    K903463 IVT INTRODUCER SHEATH
    K901767 MODIFIED IVT PERIPHERAL ATHERECTOMY
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    K895903 IVT 0.014 GUIDE WIRE
    K892209 APTT BY HEMOCHRON(R)
    K890515 PERIPHERAL ATHERECTOMY SYSTEM
    K882804 0.014 PERIPHERAL GUIDE WIRE
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