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

    ACE Hemoglobin A1c (HbA1c) Reagent

    K Number: K170623 · Decision Feb 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    248
    Applicant Total
    2
    Review Days
    363

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    Basic Information

    Device Name
    ACE Hemoglobin A1c (HbA1c) Reagent
    K Number
    K170623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7470
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Wassermann Diagnostic Technologies, LLC
    Date Received
    March 1, 2017
    Decision Date
    February 27, 2018
    Product Code
    LCP
    Advisory Committee
    Hematology
    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
    LCP Assay, Glycosylated Hemoglobin

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    Other Clearances by Alfa Wassermann Diagnostic Technologies, LLC

    K Number Device Name
    K131351 ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT