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

    SERI-SEP SERUM/PLASMA ISLOLATOR

    K Number: K781629 · Decision Oct 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    4
    Review Days
    32

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    Basic Information

    Device Name
    SERI-SEP SERUM/PLASMA ISLOLATOR
    K Number
    K781629
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Wako Intl., Inc.
    Date Received
    September 25, 1978
    Decision Date
    October 27, 1978
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Wako Intl., Inc.

    K Number Device Name
    K790768 WAKO CHOLESTEROL TEST
    K781899 UREA NITROGEN TEST
    K781342 GLUCOSE TEST