GHC · Tube, Sedimentation Rate
Hematology · 21 CFR 864.6700 · Class 1
Overview
| Product Code | GHC |
|---|---|
| Device Name | Tube, Sedimentation Rate |
| Regulation | 21 CFR 864.6700 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K885114 | SALMONELLA IFA* | Investigacion Farmaceutica S.A. DE C.V. | Aug 15, 1989 | SESE |
Top Applicants
- Investigacion Farmaceutica S.A. DE C.V. — 1 clearance
