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510(k) Data Aggregation
K Number
K980047Device Name
URISCAN S-300 SEMI-AUTOMATED URINE CHEMISTRY ANALYZER
Manufacturer
Date Cleared
1998-06-10
(155 days)
Regulation Number
862.2900Why 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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