BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    E. COLI 0157 ELISA STOOL ASSAY

    K Number: K942705 · Decision Sep 27, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    13
    Applicant Total
    12
    Review Days
    476

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    Basic Information

    Device Name
    E. COLI 0157 ELISA STOOL ASSAY
    K Number
    K942705
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lmd Laboratories
    Date Received
    June 8, 1994
    Decision Date
    September 27, 1995
    Product Code
    GMZ
    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
    GMZ Antigens, All Types, Escherichia Coli

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