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

    LMD CRYPTOSPORIDIUM ANTIGEN DETECTION

    K Number: K955345 · Decision Jun 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    14
    Applicant Total
    12
    Review Days
    199

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    Basic Information

    Device Name
    LMD CRYPTOSPORIDIUM ANTIGEN DETECTION
    K Number
    K955345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lmd Laboratories
    Date Received
    November 21, 1995
    Decision Date
    June 7, 1996
    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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