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

    MUREX SUDS RUBELLA

    K Number: K861282 · Decision Jun 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    93
    Applicant Total
    5
    Review Days
    67

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    Basic Information

    Device Name
    MUREX SUDS RUBELLA
    K Number
    K861282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3510
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Murex Corp.
    Date Received
    April 7, 1986
    Decision Date
    June 13, 1986
    Product Code
    LFX
    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
    LFX Enzyme Linked Immunoabsorbent Assay, Rubella

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    Other Clearances by Murex Corp.

    K Number Device Name
    K862048 SUDS(HCG)CONTROL SET (URINE&SERUM) & HCG REF.SERUM
    K861458 MUREX SUDS TOXO
    K860451 MUREX (TM), SUDS (TM), HCG ASSAY
    K860576 MUREX SUDS GROUP A STREP