21 CFR 864.6100
§ 864.6100 Bleeding time device.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 864.6100, § 864.6100 Bleeding time device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/89349
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Full text
(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 of this chapter subject to § 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.