CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES)
Device Facts
| Record ID | K873304 |
|---|---|
| Device Name | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) |
| Applicant | Miles Laboratories, Inc. |
| Product Code | LJX · Hematology |
| Decision Date | Sep 11, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7675 |
| Device Class | Class 1 |
Regulatory Classification
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.
