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

    RAPIDEC COLI

    K Number: K890626 · Decision Jun 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    48
    Applicant Total
    6
    Review Days
    115

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    Basic Information

    Device Name
    RAPIDEC COLI
    K Number
    K890626
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Dms Products, Inc.
    Date Received
    February 7, 1989
    Decision Date
    June 2, 1989
    Product Code
    JSS
    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
    JSS Kit, Identification, Enterobacteriaceae

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    Other Clearances by Dms Products, Inc.

    K Number Device Name
    K891004 RAPIDEC STAPH
    K894805 RAPIDEC UR
    K890625 JAMES REAGENT
    K854733 API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)
    K854732 API 50 CHB (CULTURE MEDIA)