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

    IDS STAPHYLOCHROME TEST

    K Number: K822144 · Decision Aug 24, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    19
    Applicant Total
    11
    Review Days
    34

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    Basic Information

    Device Name
    IDS STAPHYLOCHROME TEST
    K Number
    K822144
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Innovative Diagnostic Systems, Inc.
    Date Received
    July 21, 1982
    Decision Date
    August 24, 1982
    Product Code
    JWX
    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
    JWX Kit, Screening, Staphylococcus Aureus

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    Other Clearances by Innovative Diagnostic Systems, Inc.

    K Number Device Name
    K962966 IDS RAPID CB PLUS SYSTEM
    K943621 RAPID YEAST PLUS SYSTEM
    K900517 RAPID NF SYSTEM
    K882960 IDS RAPID ANA SYSTEM
    K881501 MODIFIED IDS RAPID NH SYSTEM
    K852871 IDS RAPID SS/U SYSTEM
    K852110 IDS RAPID E PLUS SYSTEM
    K833654 IDS RAPID STR SYSTEM
    K820483 IDA RAPID O2A SYSTEM
    K812859 IDS PORPHYRIN REAGENT
    Search all 11 clearances from Innovative Diagnostic Systems, Inc. →