JBO · Test, Euglobulin Lysis
Hematology · 21 CFR 864.7275 · Class 2
Overview
| Product Code | JBO |
|---|---|
| Device Name | Test, Euglobulin Lysis |
| Regulation | 21 CFR 864.7275 |
| Device Class | Class 2 |
| Review Panel | Hematology |
Identification
A euglobulin lysis time test is a device that measures the length of time required for the lysis (dissolution) of a clot formed from fibrinogen in the euglobulin fraction (that fraction of the plasma responsible for the formation of plasmin, a clot lysing enzyme). This test evaluates natural fibrinolysis (destruction of a blood clot after bleeding has been arrested). The test also will detect accelerated fibrinolysis.
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 the limitations in § 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 the limitations in § 864.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831055 | HEMOGLOBIN ELECTROPHORESIS METH ON THE- | Olympus Corp. | Jun 8, 1983 | SESE |
Top Applicants
- Olympus Corp. — 1 clearance
