21 CFR 864.5400
§ 864.5400 Coagulation instrument.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 864.5400, § 864.5400 Coagulation instrument, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89338
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ys:prov:89338@1- SHA-256
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Full text
(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 (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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.