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

    PHADECODE XA INHIBITOR ASSAY

    K Number: K792019 · Decision Nov 5, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    55
    Applicant Total
    24
    Review Days
    27

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    Basic Information

    Device Name
    PHADECODE XA INHIBITOR ASSAY
    K Number
    K792019
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7060
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Pharmaseal Div., Baxter Healthcare Corp.
    Date Received
    October 9, 1979
    Decision Date
    November 5, 1979
    Product Code
    JBQ
    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
    JBQ Antithrombin Iii Quantitation

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    Other Clearances by Pharmaseal Div., Baxter Healthcare Corp.

    K Number Device Name
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    K791156 AMIPAQUE MYELOGRAM TRAY
    K790896 TWO-WAY ANESTHESIA FILTER
    K790409 LOW DEAD SPACE INSULIN SYRINGE
    K782069 TRAY, AUXILLARY BLOCK
    K781797 PREP TRAY, PREOPERATIVE SKIN
    K781680 MONITORING, PRESSURE KIT
    K780887 IMPROVED DISPOSABLE HYPODERMIC NEEDLE
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