Q.I.C. BLEEDING TIME DEVICE
Device Facts
| Record ID | K871318 |
|---|---|
| Device Name | Q.I.C. BLEEDING TIME DEVICE |
| Applicant | Helena Laboratories |
| Product Code | JCA · Hematology |
| Decision Date | Jun 10, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6100 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
