BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Endotoxin Activity Assay (EAA)

    K Number: K183176 · Decision Mar 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    116

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    Basic Information

    Device Name
    Endotoxin Activity Assay (EAA)
    K Number
    K183176
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.3210
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Spectral Medical, Inc.
    Date Received
    November 16, 2018
    Decision Date
    March 12, 2019
    Product Code
    NGS
    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
    NGS Assay, Endotoxin Activity, Chemiluminescent

    Similar 510(k) Clearances

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

    ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE

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

    Other Clearances by Spectral Medical, Inc.

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    K170790 SAM CRRT Unit, SAM Cassette CRRT