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

    MUREX (TM), SUDS (TM), HCG ASSAY

    K Number: K860451 · Decision Apr 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    5
    Review Days
    75

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    Basic Information

    Device Name
    MUREX (TM), SUDS (TM), HCG ASSAY
    K Number
    K860451
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Murex Corp.
    Date Received
    February 5, 1986
    Decision Date
    April 21, 1986
    Product Code
    LCX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

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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
    K860576 MUREX SUDS GROUP A STREP