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

    ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT

    K Number: K131515 · Decision Aug 14, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    85
    Applicant Total
    4
    Review Days
    78

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    Basic Information

    Device Name
    ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT
    K Number
    K131515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1700
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Wassermann
    Date Received
    May 28, 2013
    Decision Date
    August 14, 2013
    Product Code
    KLI
    Advisory Committee
    Clinical Chemistry
    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
    KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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    Other Clearances by Alfa Wassermann

    K Number Device Name
    K113382 ACE ALT REAGENT
    K113436 ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT
    K113435 ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT