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

    COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL

    K Number: K972449 · Decision Aug 20, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    51

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
    K Number
    K972449
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Copan Italia Spa
    Date Received
    June 30, 1997
    Decision Date
    August 20, 1997
    Product Code
    JSL
    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
    JSL Culture Media, Anaerobic Transport

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JSL), ordered by most recent decision date.

    COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL

    FDA 510(k)
    FDA Class 1 ·Microbiology

    KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BIONOR TRANSPORTMEDIUM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ANAEROBIC TRANSPORT MEDIUM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    ANA TRANS TUBE & SWABS STERILE PACK

    FDA 510(k)
    FDA Class 1 ·Microbiology

    PRE-REDUCED ANAEROBIC MEDIA

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Copan Italia Spa

    K Number Device Name
    K232565 UriSponge™
    K232357 Copan Universal Transport Medium (UTM-RT) System
    K220052 Copan FecalSwab Collection, Transport and Preservation System
    K201849 eNAT molecular collection and preservation medium
    K180052 UriSwab-Urine Collection, Transport and Preservation System
    K142094 COPAN FECALSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM
    K972448 COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL