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

    RAPIDEC STAPH

    K Number: K891004 · Decision Nov 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    254

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    Basic Information

    Device Name
    RAPIDEC STAPH
    K Number
    K891004
    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 28, 1989
    Decision Date
    November 9, 1989
    Product Code
    LQL
    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
    LQL Gram Positive Identification Panel

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    RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA

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    Other Clearances by Dms Products, Inc.

    K Number Device Name
    K894805 RAPIDEC UR
    K890626 RAPIDEC COLI
    K890625 JAMES REAGENT
    K854733 API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT)
    K854732 API 50 CHB (CULTURE MEDIA)