JCA · Device, Bleeding Time
Hematology · 21 CFR 864.6100 · Class 2
Overview
| Product Code | JCA |
|---|---|
| Device Name | Device, Bleeding Time |
| Regulation | 21 CFR 864.6100 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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.
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.
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K911745 | SIMPLATE PEDIATRIC | Organon Teknika Corp. | Aug 9, 1991 | SESE |
| K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | International Technidyne Corp. | Jul 17, 1991 | SESE |
| K871318 | Q.I.C. BLEEDING TIME DEVICE | Helena Laboratories | Jun 10, 1987 | SESE |
| K850542 | SURGICUTT - BLEEDING TIME DEVICE | International Technidyne Corp. | Mar 1, 1985 | SESE |
| K830645 | BLEEDING TIME DEVICE DISPOSABLE | American Dade | Mar 17, 1983 | SESE |
| K801815 | AUTOLET | Ulster Scientific, Inc. | Oct 10, 1980 | SESE |
| K761250 | SIMPLATE | General Diagnostics | Mar 1, 1977 | SESE |
Top Applicants
- International Technidyne Corp. — 2 clearances
- American Dade — 1 clearance
- General Diagnostics — 1 clearance
- Helena Laboratories — 1 clearance
- Organon Teknika Corp. — 1 clearance
