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

    ACCESSORY MEDIA FOR FLOW TITERTEK MIC

    K Number: K822119 · Decision Aug 3, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    57
    Review Days
    15

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    Basic Information

    Device Name
    ACCESSORY MEDIA FOR FLOW TITERTEK MIC
    K Number
    K822119
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Flow Laboratories, Inc.
    Date Received
    July 19, 1982
    Decision Date
    August 3, 1982
    Product Code
    JTZ
    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
    JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

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    Other Clearances by Flow Laboratories, Inc.

    K Number Device Name
    K861897 UNISKAN II
    K862066 TITERTEK MICROPLATE WASHER S-12
    K861823 GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)
    K861824 GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)
    K861791 PENICILLIN-STREPTOMYCIN-FUNGIZONE
    K860752 GOAT SERUM (29-391-54)
    K860762 GAMMA-FREE HORSE SERUM
    K850908 TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA
    K844418 TITERTEK MULTISKAN MCC
    K844419 TITERTEK MULTISKAN MSS/340
    Search all 57 clearances from Flow Laboratories, Inc. →