BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    E.COLI 0157 LATEX TEST

    K Number: K944421 · Decision Dec 15, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    13
    Applicant Total
    5
    Review Days
    119

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    Basic Information

    Device Name
    E.COLI 0157 LATEX TEST
    K Number
    K944421
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pro-Lab Diagnostics
    Date Received
    August 18, 1994
    Decision Date
    December 15, 1994
    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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    Other Clearances by Pro-Lab Diagnostics

    K Number Device Name
    K924331 TRANSYSTEM LIQUID STUART MEDIUM
    K924330 TRANSYSTEM AMIES WITH CHARCOAL
    K924329 TRANSYSTEM AMIES W/O CHARCOAL
    K924328 TRANSYSTEM LIQUID AMIES MEDIUM