BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Cliawaived Inc. Auto Urinalysis Reagent Strips

    Reg #: 2531491 · FEI: 3003516723 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    ACON LABORATORIES, INC.
    Registration Number
    2531491
    FEI Number
    3003516723
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    9440 Carroll Park Drive
    City
    SAN DIEGO
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K061559

    Owner / Operator

    Firm Name
    ACON Laboratories, Inc.
    Operator Number
    9063887
    Address
    5850 Oberlin Drive, #340
    City
    San Diego
    State
    CA
    Postal Code
    92121
    Country
    US
    Correspondent
    Catherine Shi

    Products

    Device Name Product Code
    Method, Enzymatic, Glucose (Urinary, Non-Quantitative) JIL
    Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) JMT
    Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) CDM
    Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) JIR
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Dye-Indicator, Ph (Urinary, Non-Quantitative) CEN
    Test, Urine Leukocyte LJX
    Blood, Occult, Colorimetric, In Urine JIO
    Refractometer For Clinical Use JRE
    Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) JJB
    Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) JMA

    Proprietary Names

    Cliawaived Inc. Auto Urinalysis Reagent Strips ACON URINALYSIS REAGENT STRIPS McKesson CONSULT® Urinalysis Reagent Strips Mission Urinalysis Reagent Strips

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device