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

    CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT

    K Number: K834115 · Decision Mar 23, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    69
    Applicant Total
    35
    Review Days
    115

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    Basic Information

    Device Name
    CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT
    K Number
    K834115
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2450
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bartels Immunodiagnostic Supplies, Inc.
    Date Received
    November 29, 1983
    Decision Date
    March 23, 1984
    Product Code
    JSK
    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
    JSK Supplement, Culture Media

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    K860279 CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT
    K855034 AMERICAN HISTO-ID SYS PRIMARY KIT PSA PROSTATE ANT
    K842830 IMMUNOPER-OXIDASE TEST KIT FOR DETECT OF
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    K844105 FITC LABELED CHLAMYDIAE MONOCLONAL ANTIBODY
    K842834 HEP-2 CELLS
    K842833 PMK PRIMARY MONKEY KIDNEY-CELLS
    K842328 AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
    Search all 35 clearances from Bartels Immunodiagnostic Supplies, Inc. →