BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    10B ARGININE BROTH

    K Number: K961046 · Decision Sep 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    10
    Review Days
    187

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    Basic Information

    Device Name
    10B ARGININE BROTH
    K Number
    K961046
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Remel, L.P.
    Date Received
    March 15, 1996
    Decision Date
    September 18, 1996
    Product Code
    JSM
    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
    JSM Culture Media, Non-Propagating Transport

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