# K140690: BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 2, 2014 after 167 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953239 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112377: BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2012) Summary page 5.

## Indications for use
The BS-480/BS-490/CLC720i chemistry analyzer is designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), Cl-(chloride) in serum, plasma and urine samples and Urea Nitrogen in serum samples. Additionally, other various chemistry tests may be adaptable to the analyzer depending on the reagent used to induce a photometric reaction. Sodium measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders. Urea Nitrogen (BUN) measurements are used to aid in the determination of liver and kidney functions and other diseases associated with protein catabolism.

Source page: https://510kreport.com/device/K140690
Methodology: https://510kreport.com/methodology