HEMOGLOBIN ELECTROPHORESIS METH ON THE-
Device Facts
| Record ID | K831055 |
|---|---|
| Device Name | HEMOGLOBIN ELECTROPHORESIS METH ON THE- |
| Applicant | Olympus Corp. |
| Product Code | JBO · Hematology |
| Decision Date | Jun 8, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7275 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.
