# K980047: Uriscan S-300 Semi-Automated Urine Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Yeongdong Pharmaceutical Corp.
- Decided: Jun 10, 1998 after 155 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K842237 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842237: Clinitek 200 Semi-Automated Urinalysis, Miles Laboratories, Inc. (1984) Summary page 2.
- K934042: Chemstrip Super UA Urine Analyzer, Boehringer Mannheim Corp. (1993) Summary page 2.
- (no number) Boehringer Mannheim Chemstrip Super UA Urine Analyzer: named in the summary without a submission number

## Indications for 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 Ascorbi Acid in urine specimens through the reflectance method.

Source page: https://510kreport.com/device/K980047
Methodology: https://510kreport.com/methodology