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

    PROSPECT(TM/CRYPTOSPORIDIUM

    K Number: K912242 · Decision Mar 23, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    14
    Applicant Total
    10
    Review Days
    307

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    Basic Information

    Device Name
    PROSPECT(TM/CRYPTOSPORIDIUM
    K Number
    K912242
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alexon, Inc.
    Date Received
    May 21, 1991
    Decision Date
    March 23, 1992
    Product Code
    MHJ
    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
    MHJ Cryptosporidium Spp.

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