21 CFR 864.6100 - Bleeding time device.
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(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.
[45 FR 60604, Sept. 12, 1980, as amended at 63 FR 59225, Nov. 3, 1998]
Title 21 published on 2015-04-01.
No entries appear in the Federal Register after this date, for 21 CFR Part 864.