BC-3200 Auto Hematology Analyzer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K063407 FDA 510(k)
- FDA Product Code
- GKZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.5220 FDA 510(k)
- Regulation Number
- 864.5220 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BC-3200 Auto Hematology Analyzer is a Counter, Differential Cell device, designed for automated hematological analysis. It performs differential cell counting and provides measurements of blood parameters, including red blood cells, white blood cells, hemoglobin, and platelets, to support diagnostic evaluations in hematology.
This device is intended for use in clinical laboratories and healthcare settings, operating as a reusable instrument. It requires no specific sterility classification as per the provided data and is not labeled for MRI compatibility. The analyzer is authorized under FDA 510K, IVDD, and IVDR frameworks, adhering to regulatory standards for hematology analyzers. Storage and maintenance follow manufacturer guidelines to ensure accurate and reliable performance.
Frequently asked questions
What types of blood parameters does the BC-3200 Auto Hematology Analyzer measure, and how does this support clinical decision-making?
The BC-3200 Auto Hematology Analyzer measures key blood parameters including red blood cells, white blood cells, hemoglobin, and platelets. These measurements enable automated differential cell counting, which helps clinicians assess hematological conditions such as anemia, infections, or blood disorders by providing precise and rapid quantitative data for diagnostic evaluations.
Is the BC-3200 Auto Hematology Analyzer designed for single-use or reusable operation, and what does this mean for maintenance?
The BC-3200 is a reusable instrument, meaning it is built for repeated use in clinical settings. This design requires adherence to manufacturer guidelines for storage, cleaning, and maintenance to ensure consistent performance, accuracy, and reliability over time.
What regulatory frameworks does the BC-3200 Auto Hematology Analyzer comply with, and how does this affect its use in different regions?
The device is authorized under the FDA 510K pathway, as well as the In Vitro Diagnostic Device Directives (IVDD) and In Vitro Diagnostic Regulation (IVDR) frameworks. This means it meets regulatory standards for hematology analyzers in the U.S. and the European Economic Area, ensuring compliance with local requirements for clinical laboratory use.
Does the BC-3200 Auto Hematology Analyzer require any special handling for sterility, and where would it typically be used?
The device is not labeled with a specific sterility classification, indicating it is not intended for sterile procedures. It is designed for use in clinical laboratories and healthcare settings where routine hematological analysis is performed, such as hospitals, diagnostic centers, or specialized hematology labs.
How is the BC-3200 Auto Hematology Analyzer classified in terms of medical specialty, and what does this imply for its intended users?
The device falls under the medical specialty of hematology, as indicated by its regulatory classification. This means it is specifically intended for use by healthcare professionals, such as laboratory technicians or hematologists, who specialize in diagnosing and treating blood-related conditions.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K063407 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K063407 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced Jun 2, 2026