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

    Diazyme PLAC® Test for Lp-PLA2 Activity

    K Number: K203136 · Decision Aug 6, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    11
    Review Days
    290

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    Basic Information

    Device Name
    Diazyme PLAC® Test for Lp-PLA2 Activity
    K Number
    K203136
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    866.5600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Diazyme Laboratories, Inc.
    Date Received
    October 20, 2020
    Decision Date
    August 6, 2021
    Product Code
    NOE
    Advisory Committee
    Immunology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2

    Similar 510(k) Clearances

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

    PLAC TEST FOR LP-PLA2 ACTIVITY

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    PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115

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    FDA Class 2 ·Immunology

    PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109

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    MODIFICATION TO DIADEXUS PLAC TEST

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    DIADEXUS PLAC TEST

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    MODIFICATION TO DIADEXUS PLAC TEST

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