---
kind: "section"
citation: "21 C.F.R. § 864.6100"
title: "21"
number: "864.6100"
heading: "Bleeding time device."
url: "https://uscodex.org/cfr/21/864.6100"
---

# §864.6100. Bleeding time device.

- (a) **Identification.** A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.
- (b) **Classification.** Class II (special controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 864.9](/cfr/21/864.9.md).

## Notes

### Amendments

[45 FR 60604, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Amendments

[45 FR 60604, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]