DILULAB 230
Device Facts
| Record ID | K823522 |
|---|---|
| Device Name | DILULAB 230 |
| Applicant | Innovative Medical Systems, Inc. |
| Product Code | GKH · Hematology |
| Decision Date | Dec 28, 1982 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5240 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.