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

    INDOLE REAGENT

    K Number: K842872 · Decision Aug 3, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    86
    Applicant Total
    10
    Review Days
    11

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    Basic Information

    Device Name
    INDOLE REAGENT
    K Number
    K842872
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2320
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Irvine Diagnostic Services
    Date Received
    July 23, 1984
    Decision Date
    August 3, 1984
    Product Code
    JSF
    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
    JSF Culture Media, Single Biochemical Test

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    Other Clearances by Irvine Diagnostic Services

    K Number Device Name
    K842871 HIPPURATE TEST REAGENT
    K842869 DECARBOXYLASE TEST REAGENT
    K842870 VOGES-PROSKAUER REAGENT A
    K842868 HIPPURATE TEST DISKS
    K842867 VOGES-PROSKAUER REAGENT B
    K842299 ZINC DUST SUSPENSION
    K842298 OXIDASE TEST STRIPS-OXIDASESURE
    K842300 ONPG DISKS
    K842072 L-ALANINE-4-NITROANILIDE