WESTERGREN DISPETTE FOR ESR
Device Facts
| Record ID | K831195 |
|---|---|
| Device Name | WESTERGREN DISPETTE FOR ESR |
| Applicant | Ulster Scientific, Inc. |
| Product Code | JPH · Hematology |
| Decision Date | May 9, 1983 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6700 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.
