GKB · Device, Automated Sedimentation Rate
Hematology · 21 CFR 864.5800 · Class 1
Overview
| Product Code | GKB |
|---|---|
| Device Name | Device, Automated Sedimentation Rate |
| Regulation | 21 CFR 864.5800 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K892522 | SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED | Gespac, Inc. | May 24, 1989 | SESE |
| K890503 | SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE | Gespac, Inc. | Feb 10, 1989 | SESE |
Top Applicants
- Gespac, Inc. — 2 clearances
