← Product Code [LGO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LGO) · K761009

# LYMPHOCYTE TYPING, POSITIVE CONTROL (K761009)

_Hyland Therapeutic Div., Travenol Laboratories · LGO · Apr 6, 1977 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LGO/K761009

## Device Facts

- **Applicant:** Hyland Therapeutic Div., Travenol Laboratories
- **Product Code:** [LGO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LGO.md)
- **Decision Date:** Apr 6, 1977
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7675
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LGO/K761009](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LGO/K761009)

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