CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
Device Facts
| Record ID | K873348 |
|---|---|
| Device Name | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. |
| Applicant | Abbott Diagnostics |
| Product Code | GGK · Hematology |
| Decision Date | Sep 9, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8540 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
