BS-200 Chemistry Analyzer
by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
510(k) K072018
Active
Valid until
Not listed
FDA recalls
None ongoingTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK072018 | Date1 Feb 2008 | StatusActive |
| European Union | CE/IVDR EUDAMED | Number— | Date— | StatusActive |
Recalls
-
- Terminated Z-0977-2013
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- Bs-200 Chemistry Analyzer, Mode Bs-200
- 510(k) Number
- FDA Product Code
- CFR
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The BS-200 Chemistry Analyzer is a clinical chemistry instrument designed for automated biochemical analysis. It measures a range of analytes, including glucose, hexokinase, and other biochemical parameters, to support diagnostic testing in clinical settings.
This bench-top device operates in discrete and random-access modes, requiring trained personnel for operation. Supplied as a reusable instrument, it is intended for use in regulated clinical chemistry laboratories. Authorized under FDA 510(k) and IVDR compliance, the BS-200 adheres to medical device standards for biochemical testing, with no specific MRI safety or sterility requirements noted in the data.
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Questions
AI-generated answers, 18 Sep 2026
What types of biochemical tests can the BS-200 Chemistry Analyzer perform, and how does its random-access capability benefit clinical workflows?
The BS-200 Chemistry Analyzer measures a broad range of analytes, including glucose and hexokinase, as well as other biochemical parameters commonly used in clinical chemistry. Its random-access mode allows laboratories to prioritize and process tests as they arrive, rather than waiting for a full batch, which improves turnaround time and operational flexibility for urgent or high-priority diagnostic needs.
Is the BS-200 Chemistry Analyzer designed for single-use or reusable operation, and what training is required for its use?
The BS-200 Chemistry Analyzer is a reusable bench-top instrument, meaning it is built for long-term use in clinical chemistry laboratories. Since it requires trained personnel for operation, it is intended for settings where staff have experience with automated biochemical analyzers and can properly maintain, calibrate, and troubleshoot the device.
How does the BS-200 Chemistry Analyzer’s regulatory compliance affect its suitability for clinical use in the U.S.?
The BS-200 Chemistry Analyzer holds FDA 510(k) clearance and IVDR compliance, confirming it meets U.S. and European Union regulatory standards for clinical chemistry instruments. This authorization ensures it adheres to safety, performance, and quality requirements for biochemical testing in regulated laboratory environments, providing confidence in its reliability for diagnostic applications.
Does the BS-200 Chemistry Analyzer include any special handling or storage requirements, such as sterility or environmental conditions?
The BS-200 Chemistry Analyzer is not described as sterile, so it does not require sterile handling like disposable consumables. However, as a reusable medical device, it should be stored in a clean, dry environment protected from dust, moisture, and extreme temperatures to maintain its performance and longevity. Proper maintenance and calibration procedures should also be followed as per the manufacturer’s guidelines.