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

    PLASMA, STANDARDIZED NORMAL

    K Number: K790204 · Decision Mar 12, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    180
    Applicant Total
    44
    Review Days
    41

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    Basic Information

    Device Name
    PLASMA, STANDARDIZED NORMAL
    K Number
    K790204
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Dade, Baxter Travenol Diagnostics, Inc.
    Date Received
    January 30, 1979
    Decision Date
    March 12, 1979
    Product Code
    JPA
    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
    JPA System, Multipurpose For In Vitro Coagulation Studies

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    Other Clearances by Dade, Baxter Travenol Diagnostics, Inc.

    K Number Device Name
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    K792606 WHOLE BLOOD PLATELET CONTROL NORMAL,
    K792723 BLOOD FLUID FILTERS
    K792607 T3 UPTAKE (T3U) REAGENTS
    K792443 TSH RADIOIMMUNOASSAY
    K792442 FERRITIN RADIOIMMUNOASSAY
    K791922 HARLECO BRAND CLINICARD LIPASE TEST SET
    K792183 DADE HIGH DENSITY LIPOPROTEIN CHOLESTERO
    K790767 IMMU-TEK AUTOMATIC CENTRIFUGE
    K790776 DADE LOW IONIC STRENGTH SOLUITION (LISS)
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