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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 864 - Hematology and Pathology Devices |
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Subpart F - Automated and Semi-Automated Hematology Devices |
§ 864.5950 - Blood volume measuring device.
Latest version.
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§ 864.5950 Blood volume measuring device.
(a) Identification. A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.
(b) Classification. Class II (performance standards).
[45 FR 60603, Sept. 12, 1980]