21 CFR 864.6100 — Device, Bleeding Time
Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6100
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JCA | Device, Bleeding Time | 2 | 7 |
Special Controls
JCA — Device, Bleeding Time
*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.
eCFR
