21 C.F.R. § 864.6100   Bleeding time device.

Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart G—Manual Hematology Devices

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§ 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 of this chapter subject to §864.9.

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

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