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

    SGOT REAGENT SET

    K Number: K821209 · Decision Jul 14, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    6
    Applicant Total
    21
    Review Days
    78

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    Basic Information

    Device Name
    SGOT REAGENT SET
    K Number
    K821209
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1100
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Omega Medical Electronics
    Date Received
    April 27, 1982
    Decision Date
    July 14, 1982
    Product Code
    CIQ
    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
    CIQ Diazo, Ast/Sgot

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    Other Clearances by Omega Medical Electronics

    K Number Device Name
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    K821212 UREA NITROGEN REAGENT SET
    K821201 LDH-UV REAGENT SET
    K821205 TRIGLYCERIDE REAGENT SET
    K821208 SGOT-UV REAGENT SET
    K821207 SGPT REAGENT SET
    K821199 CREATININE REAGENT SET
    K821210 SERUM TOTAL PROTEIN REAGENT SET
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