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

    READAR

    K Number: K925951 · Decision Aug 31, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    44
    Applicant Total
    26
    Review Days
    280

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    Basic Information

    Device Name
    READAR
    K Number
    K925951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alamar Biosciences Laboratory, Inc.
    Date Received
    November 24, 1992
    Decision Date
    August 31, 1993
    Product Code
    LRG
    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
    LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

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    Other Clearances by Alamar Biosciences Laboratory, Inc.

    K Number Device Name
    K941425 ALAMAR ANTIBIOTIC SUSCEPTIBILITY
    K926248 READER
    K926002 ALAMAR BACTERIAL IDENTIFICATION TEST PANEL
    K930469 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K930055 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K924500 ANTIMICROBIAL SUSCEPTIBILITY TEST
    K922780 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K922003 ANTIMICROBIAL SUSCETIBILITY TEST PANEL
    K922168 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K911558 ANTIMICROBIAL SUSCEPT. TEST PANEL NITROFURANTOIN
    Search all 26 clearances from Alamar Biosciences Laboratory, Inc. →