Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7275](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7275) → JBO — Test, Euglobulin Lysis

# JBO · Test, Euglobulin Lysis

_Hematology · 21 CFR 864.7275 · Class 2_

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

## Overview

- **Product Code:** JBO
- **Device Name:** Test, Euglobulin Lysis
- **Regulation:** [21 CFR 864.7275](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7275)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## 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](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBO/K831055.md) | HEMOGLOBIN ELECTROPHORESIS METH ON THE- | Olympus Corp. | Jun 8, 1983 | SESE |

## Top Applicants

- Olympus Corp. — 1 clearance

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

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