← Product Code [JBO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBO) · K831055

# HEMOGLOBIN ELECTROPHORESIS METH ON THE- (K831055)

_Olympus Corp. · JBO · Jun 8, 1983 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBO/K831055

## Device Facts

- **Applicant:** Olympus Corp.
- **Product Code:** [JBO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBO.md)
- **Decision Date:** Jun 8, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7275
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBO/K831055](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBO/K831055)

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