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

    SHIGELLA SERA-CHEK

    K Number: K813191 · Decision Dec 3, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    16

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    Basic Information

    Device Name
    SHIGELLA SERA-CHEK
    K Number
    K813191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Lab Ability, Inc.
    Date Received
    November 17, 1981
    Decision Date
    December 3, 1981
    Product Code
    LIA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LIA Antigens, All Groups, Shigella Spp.

    Other Clearances by Lab Ability, Inc.

    K Number Device Name
    K833407 SELECTO-DISC NOVOBIOCIN 5UG
    K832436 SELECTRO-DISC
    K830133 Q-CHECK CULTI-LOOPS
    K830134 Q-CHECK REAGENT STANDARDS