# K112377: BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Mar 23, 2012 after 219 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953239 (1995). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904219: Synchron CX 7 Clinical Analyzer, Beckman (1990) Summary page 2.
- K072018: BS-200 Chemistry Analyzer, Mode BS-200, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 2.
- K970664: Glucose Reagent, Derma Media Lab., Inc. (1997) Summary page 2.

## Most influential descendants
- K140690: BS-480 Chemistry Analyzer, BS-490 Chemistry Analyzer, CLC720I Chemistry Analyzer (2014), 0 descendants of its own

## Indications for use
The BS-400/CLC 720 Chemistry Analyzers are designed for clinical laboratory use, making direct quantitative measurements of Na+ (sodium), K+ (potassium), CI- (chloride) in serum, plasma and urine samples and Glucose in serum samples plasma and urine samples. Additionally, other various chemistry assays 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. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Source page: https://510kreport.com/device/K112377
Methodology: https://510kreport.com/methodology