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

    MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN

    K Number: K981199 · Decision Nov 18, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    44
    Applicant Total
    40
    Review Days
    230

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    Basic Information

    Device Name
    MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN
    K Number
    K981199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dade Microscan, Inc.
    Date Received
    April 2, 1998
    Decision Date
    November 18, 1998
    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 Dade Microscan, Inc.

    K Number Device Name
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    K023202 MICROSCAN SYNERGIES PLUS
    K021184 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
    K021181 MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYCIN
    K021018 MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL
    K021188 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME
    K021169 MICROSTREP PLUS PANEL, AZITHROMYCIN
    K021111 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
    K021078 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
    K021110 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
    Search all 40 clearances from Dade Microscan, Inc. →