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

    PLAC TEST FOR LP-PLA2 ACTIVITY

    K Number: K141575 · Decision Dec 15, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    7
    Applicant Total
    7
    Review Days
    186

    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
    PLAC TEST FOR LP-PLA2 ACTIVITY
    K Number
    K141575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5600
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Diadexus, Inc.
    Date Received
    June 12, 2014
    Decision Date
    December 15, 2014
    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.

    Diazyme PLAC® Test for Lp-PLA2 Activity

    FDA 510(k)
    FDA Class 2 ·Immunology

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

    FDA 510(k)
    FDA Class 2 ·Immunology

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

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO DIADEXUS PLAC TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIADEXUS PLAC TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    MODIFICATION TO DIADEXUS PLAC TEST

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

    Other Clearances by Diadexus, Inc.

    K Number Device Name
    K101853 PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115
    K072599 PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109
    K062234 MODIFICATION TO DIADEXUS PLAC TEST
    K050523 DIADEXUS PLAC TEST
    K040101 MODIFICATION TO DIADEXUS PLAC TEST
    K030477 DIADEXUS PLAC TEST