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

    MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR

    K Number: K933121 · Decision Feb 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    13
    Review Days
    223

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    Basic Information

    Device Name
    MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
    K Number
    K933121
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bioclinical Systems, Inc.
    Date Received
    June 25, 1993
    Decision Date
    February 3, 1994
    Product Code
    JTY
    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
    JTY Culture Media, For Isolation Of Pathogenic Neisseria

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    Other Clearances by Bioclinical Systems, Inc.

    K Number Device Name
    K950196 CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA
    K945911 CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS
    K933122 MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR
    K873086 ROUND 1
    K860334 VISI-CHECK HLH TEST MONOCLONAL
    K860333 MICRO-ELISA HLH TEST KIT MONOCLONAL
    K855227 MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL
    K854059 MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO
    K854379 MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT
    K850257 BCS GLUCOSE COLORIMETRIC TEST
    Search all 13 clearances from Bioclinical Systems, Inc. →