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

    LDL CHOLESTEROL (AUTOMATED)

    K Number: K022519 · Decision Sep 30, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    20
    Review Days
    62

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    Basic Information

    Device Name
    LDL CHOLESTEROL (AUTOMATED)
    K Number
    K022519
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jas Diagnostics, Inc.
    Date Received
    July 30, 2002
    Decision Date
    September 30, 2002
    Product Code
    JHM
    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
    JHM Colorimetric Method, Lipoproteins

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    Other Clearances by Jas Diagnostics, Inc.

    K Number Device Name
    K130915 XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
    K080623 CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, MODEL NA
    K080618 DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID
    K021671 JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
    K020454 CHEMISTRY CALIBRATOR
    K020282 JAS AMYLASE LIQUID REAGENT
    K013912 CREATINE KINASE (CK-NAC)
    K013698 AST (SGOT)
    K012332 JAS CARBON DIOXIDE LIQUID REAGENT
    K012038 JAS URIC ACID LIQUID REAGENT
    Search all 20 clearances from Jas Diagnostics, Inc. →