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

    Remel Spectra ESBL

    K Number: K162620 · Decision May 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    39
    Applicant Total
    17
    Review Days
    223

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    Basic Information

    Device Name
    Remel Spectra ESBL
    K Number
    K162620
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remel, Inc.
    Date Received
    September 20, 2016
    Decision Date
    May 1, 2017
    Product Code
    JSO
    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
    JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

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    Other Clearances by Remel, Inc.

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    K041951 XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B
    K033479 PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY
    K031942 XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
    K031965 XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
    K031834 XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
    K031565 XPECT INFLUENZA A/B
    K981391 PAR-ONE
    Search all 17 clearances from Remel, Inc. →