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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 |
§ 864.5400 - Coagulation instrument.
Latest version.
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§ 864.5400 Coagulation instrument.
(a) Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
(b) Classification. Class II (performance standards). special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60598, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]