---
kind: "section"
citation: "21 C.F.R. § 864.5400"
title: "21"
number: "864.5400"
heading: "Coagulation instrument."
url: "https://uscodex.org/cfr/21/864.5400"
---

# §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 (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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 864.9](/cfr/21/864.9.md).

## Notes

### 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]