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

    REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST

    K Number: K942093 · Decision Nov 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    104
    Applicant Total
    57
    Review Days
    210

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    Basic Information

    Device Name
    REMEL RIM STREPTOCOCCUS GROUPING LATEX AGGLUTINATION TEST
    K Number
    K942093
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Diagnostic Technologies, Inc.
    Date Received
    May 2, 1994
    Decision Date
    November 28, 1994
    Product Code
    GTZ
    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
    GTZ Antisera, All Groups, Streptococcus Spp.

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