SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED
Device Facts
| Record ID | K892522 |
|---|---|
| Device Name | SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED |
| Applicant | Gespac, Inc. |
| Product Code | GKB · Hematology |
| Decision Date | May 24, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5800 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.
