BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Manual Antimicrobial Susceptibility Test Systems

    PMA: P830028 · Decision Mar 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10

    Basic Information

    Device Name
    Manual Antimicrobial Susceptibility Test Systems
    Trade Name
    UNISCEPT(TM)
    PMA Number
    P830028
    Device Class
    FDA Class 2
    Product Code
    JWY
    Generic Name
    Manual antimicrobial susceptibility test systems
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Advisory Committee
    Microbiology
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    March 1, 1984
    Date Received
    March 25, 1983
    Expedited Review
    N
    Docket Number
    84M-0129

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JWY Manual Antimicrobial Susceptibility Test Systems