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510(k) Data Aggregation

    K Number
    K980047
    Device Name
    URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
    Date Cleared
    1998-06-10

    (155 days)

    Product Code
    Regulation Number
    862.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    YEONGDONG PHARMACEUTICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The URiSCAN S-300 Semi-Automated Urine Chemistry Analyzer is a urine analyzer for detection of Occult Blood, Bilirubin, Urobilinogen, Ketones, Protein, Nitrite, Glucose, pH, Specific Gravity, Leukocytes and Ascorbic Acid in urine specimens through the reflectance method.
    Device Description
    The URISCAN S-300 Semi-Automated Urine Chemistry Analyzer is a line operated unit which translates color and intensity of light reflected from reacted reagent pads into clinical units and displays the results. The instrument is specifically designed to "read" YEONGDONG URiSCAN urinalysis reagent strips (See K952307). The URiSCAN S-300 Semi-Automated Urine Chemistry system includes tests for the following physical properties and chemical constituents of urine: specific gravity, pH, Blood, Bilirubin, Urobilinogen, Ketones, Protein, Nitrite, Glucose, Leukocytes and Ascorbic Acid. The instrument uses a light source produced by cold fluorescent lamp.
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