§ 864.5400. Coagulation instrument.
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/us/cfr/t21/s§ 864.5400·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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. [45 FR 60598, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]