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Quantitative determination of hemoglobin in capillary, venous and arterial whole blood.

The HemoCue® Hb 201 Microcuvettes are intended for use in the HemoCue® Hb 201 analyzer. The HemoCue 201 system is used for the quantitative determination of hemoglobin in blood using a specially designed analyzer, the HemoCue Hb 201 analyzer, and specially designed microcuvettes the HemoCue Hb 201 Microcuvettes. The HemoCue Hb 201+ analyzer is only to be used with HemoCue Hb 201 Microcuvettes.

The reagents/microcuvettes and the analyzer form an analytical system. The HemoCue Hb 201* analyzer is only to be used together with HemoCue Hb 201 microcuvettes. The use of any other device in the HemoCue Hb 201+ analyzer except the HemoCue Hb 201 microcuvettes is neither supported nor recommended by HemoCue, and could give erroneous results with serious clinical consequences.

The HemoCue Hb 201 microcuvettes are for in vitro diagnostic use only.

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This document provides an FDA 510(k) clearance letter for the HemoCue® Hb 201+ System but does not contain the detailed study information required to fully answer your request. The letter confirms the device's substantial equivalence to predicate devices and states its indications for use. It does not include acceptance criteria, specific performance data from studies, sample sizes, ground truth establishment, or any information about expert participation or multi-reader studies.

Therefore, I cannot provide the requested table and detailed study information based solely on the provided text.

The available information from the document is:

• Device Name: HemoCue® Hb 201+ System
• Intended Use: Quantitative determination of hemoglobin in capillary, venous, and arterial whole blood.
• Components: HemoCue® Hb 201+ analyzer and HemoCue® Hb 201 Microcuvettes.
• Regulatory Status: Cleared through 510(k) process, determined substantially equivalent to legally marketed predicate devices.

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