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

    MUREX SUDS GROUP A STREP

    K Number: K860576 · Decision Apr 4, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    104
    Applicant Total
    5
    Review Days
    45

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    Basic Information

    Device Name
    MUREX SUDS GROUP A STREP
    K Number
    K860576
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Murex Corp.
    Date Received
    February 18, 1986
    Decision Date
    April 4, 1986
    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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    Other Clearances by Murex Corp.

    K Number Device Name
    K862048 SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM
    K861282 MUREX SUDS RUBELLA
    K861458 MUREX SUDS TOXO
    K860451 MUREX (TM), SUDS (TM), HCG ASSAY