§864.5400. Coagulation instrument.
21 C.F.R. § 864.5400
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
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.
Notes, amendments, and revision history
Amendments
[45 FR 60598, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60598, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]