LGO · Test, Leukocyte Typing
Hematology · 21 CFR 864.7675 · Class 1
Overview
| Product Code | LGO |
|---|---|
| Device Name | Test, Leukocyte Typing |
| Regulation | 21 CFR 864.7675 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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.
Classification Rationale
Class I (general controls). This 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K894947 | PLATELIA TOXO IGG KIT | Kallestad Diag, A Div. of Erbamont, Inc. | Mar 23, 1990 | SESE |
| K874544 | SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT | Molecular Biosystems, Inc. | Aug 12, 1988 | SESE |
| K791118 | HLA CONTROL SERA | Calbiochem-Behring Corp. | Aug 3, 1979 | SESE |
| K761009 | LYMPHOCYTE TYPING, POSITIVE CONTROL | Hyland Therapeutic Div., Travenol Laboratories | Apr 6, 1977 | SESE |
| K761008 | LYMPHOCYTE TYPING, NEGATIVE CONTROL | Hyland Therapeutic Div., Travenol Laboratories | Apr 6, 1977 | SESE |
Top Applicants
- Hyland Therapeutic Div., Travenol Laboratories — 2 clearances
- Calbiochem-Behring Corp. — 1 clearance
- Kallestad Diag, A Div. of Erbamont, Inc. — 1 clearance
- Molecular Biosystems, Inc. — 1 clearance
