BS-400 Chemistry Analyzer, CLC 720 Chemistry Analyzer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K112377 FDA 510(k)
- FDA Product Code
- CFR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1345 FDA 510(k)
- Regulation Number
- 862.1345 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BS-400 Chemistry Analyzer and CLC 720 Chemistry Analyzer are automated clinical chemistry analyzers designed for the quantitative measurement of biochemical parameters in serum, plasma, or whole blood. These devices utilize enzymatic and colorimetric methods to analyze substances such as glucose, electrolytes, lipids, and enzymes, supporting diagnostic evaluations in clinical chemistry.
These analyzers are intended for use in clinical laboratory settings and are supplied as reusable medical devices. They comply with FDA 510(k) clearance (K112377) and IVDR requirements, falling under product code CFR (Class II). The devices require proper maintenance, calibration, and adherence to manufacturer instructions for operation, including storage in a controlled environment to ensure accuracy and reliability. No MRI safety information or single-use designation is specified in the data.
Frequently asked questions
Are the BS-400 and CLC 720 Chemistry Analyzers designed for single-use or reusable in clinical settings?
The BS-400 and CLC 720 Chemistry Analyzers are explicitly described as reusable medical devices. They require proper maintenance, calibration, and adherence to manufacturer instructions for reliable operation, including storage in a controlled environment to ensure accuracy.
What types of biological samples can the BS-400 and CLC 720 Chemistry Analyzers analyze, and how are they measured?
These analyzers are designed for the quantitative measurement of biochemical parameters in serum, plasma, or whole blood. They use enzymatic and colorimetric methods to analyze substances like glucose, electrolytes, lipids, and enzymes, supporting diagnostic evaluations in clinical chemistry.
What regulatory pathways have the BS-400 and CLC 720 Chemistry Analyzers followed, and what does that mean for their use?
The devices have received FDA 510(k) clearance (K112377) under the Traditional 510(k) pathway, meaning they were determined to be substantially equivalent to a legally marketed predicate device. They also comply with IVDR (In Vitro Diagnostic Regulation) requirements, indicating they meet EU regulatory standards for clinical chemistry analyzers. This clearance allows their use in clinical laboratory settings as described in the manufacturer’s instructions.
Do these analyzers require any special storage conditions, and why is this important?
Yes, the BS-400 and CLC 720 Chemistry Analyzers must be stored in a controlled environment to ensure accuracy and reliability. Proper storage is critical because these are reusable devices that rely on precise calibration and maintenance to deliver consistent biochemical measurements for diagnostic purposes.
What specific biochemical parameters can these analyzers measure, and how does that benefit clinical workflows?
While the exact parameters aren’t listed in the provided data, the analyzers are designed for quantitative measurement of key biochemical markers such as glucose, electrolytes, lipids, and enzymes. This broad capability supports diagnostic evaluations in clinical chemistry, enabling labs to assess patient health metrics efficiently—such as metabolic disorders, cardiovascular risk, or organ function—without needing multiple standalone tests.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER by SHENZHEN ..., Bs-400 Chemistry Analyzer, Clc 720 Chemistry Analyzer, Bs-400 Chemistry Analyzer, Clc 720 Chemistry Analyzer, K112377 - BS-400 CHEMISTRY ANALYZER | FDA 510 (k), Bs-400 Chemistry Analyzer, Clc 720 Chemistry Analyzer
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K112377 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K112377 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 28, 2026