BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    ACE MAGNESIUM REGENT

    K Number: K122302 · Decision Aug 27, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    89
    Applicant Total
    3
    Review Days
    26

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    Basic Information

    Device Name
    ACE MAGNESIUM REGENT
    K Number
    K122302
    Device Class
    FDA class 1
    Clearance Type
    Special
    Regulation Number
    862.1495
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alfa Wassermann Diagnostics Technologies, LLC
    Date Received
    August 1, 2012
    Decision Date
    August 27, 2012
    Product Code
    JGJ
    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
    JGJ Photometric Method, Magnesium

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    Other Clearances by Alfa Wassermann Diagnostics Technologies, LLC

    K Number Device Name
    K131488 ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
    K123322 ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT