HEMOLYSE
Device Facts
| Record ID | K863503 |
|---|---|
| Device Name | HEMOLYSE |
| Applicant | Reagent Laboratory, Inc. |
| Product Code | GGK · Hematology |
| Decision Date | Oct 3, 1986 |
| 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.
