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

    ALP REAGENT SET

    K Number: K971463 · Decision May 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    123
    Applicant Total
    20
    Review Days
    25

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    Basic Information

    Device Name
    ALP REAGENT SET
    K Number
    K971463
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carolina Liquid Chemistries Corp.
    Date Received
    April 21, 1997
    Decision Date
    May 16, 1997
    Product Code
    CJE
    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
    CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

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    Other Clearances by Carolina Liquid Chemistries Corp.

    K Number Device Name
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    K133519 CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
    K132711 CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
    K972073 TOTAL BILIRUBIN REAGENT
    K971907 CALCIUM REAGENT
    K971324 TRIGLYCERIDES, TG, OR TRIG
    K971967 BUN
    K971908 CREA OR CREATININE
    K971467 SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
    K971345 CHOL OR CHOLESTEROL
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