SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT-
Device Facts
| Record ID | K850239 |
|---|---|
| Device Name | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- |
| Applicant | Toa Medical Electronics USA, Inc. |
| Product Code | GIF · Hematology |
| Decision Date | Apr 1, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.8200 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
