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

    GILCHEM ACID PHOSPHATASE REAGENT

    K Number: K820975 · Decision Apr 26, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    23
    Applicant Total
    50
    Review Days
    20

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    Basic Information

    Device Name
    GILCHEM ACID PHOSPHATASE REAGENT
    K Number
    K820975
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1020
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Gilford Diagnostics
    Date Received
    April 6, 1982
    Decision Date
    April 26, 1982
    Product Code
    CKB
    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
    CKB Acid Phosphatase, Naphthyl Phosphate

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    Other Clearances by Gilford Diagnostics

    K Number Device Name
    K832094 BILIRUBIN CALIBRATORS & CONTROL
    K831844 DIRECT BILIRUBIN REAGENT
    K831843 GILCHEM TOTAL BILIRUBIN REAGENT
    K823709 TRIGLYCERIDE REAGENT (UV)
    K822739 AHBD
    K822334 BILIRUBIN CALIBRATORS
    K822289 CO2/CI STANDARDS
    K822149 GILCHEM Y-GT REAGENT
    K821719 AMMONIA REAGENT
    K820976 GIL CHEM MAGNESIUM REAGENT
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