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

    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME

    K Number: K021111 · Decision Jun 6, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    49
    Applicant Total
    40
    Review Days
    62

    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
    MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
    K Number
    K021111
    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 5, 2002
    Decision Date
    June 6, 2002
    Product Code
    LTT
    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
    LTT Panels, Test, Susceptibility, Antimicrobial

    Similar 510(k) Clearances

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

    MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)

    FDA 510(k)
    FDA Class 2 ·Microbiology
    View all

    Other Clearances by Dade Microscan, Inc.

    K Number Device Name
    K043589 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM
    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
    K021078 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
    K021110 MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXONE
    K020938 MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM
    Search all 40 clearances from Dade Microscan, Inc. →