JPH · Test, Erythrocyte Sedimentation Rate
Hematology · 21 CFR 864.6700 · Class 1
Overview
| Product Code | JPH |
|---|---|
| Device Name | Test, Erythrocyte 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K871076 | WINPETTE | Ulster Scientific, Inc. | Mar 23, 1987 | SESE |
| K860899 | DISPETTE II | Ulster Scientific, Inc. | Apr 14, 1986 | SESE |
| K852554 | SRT-SYSTEM | Microwave Development, Inc. | Jul 18, 1985 | SESE |
| K840500 | SEDIPLAST | Precision Technology, Inc. | Feb 21, 1984 | SESE |
| K831195 | WESTERGREN DISPETTE FOR ESR | Ulster Scientific, Inc. | May 9, 1983 | SESE |
| K823761 | ERYTHROCYTE & STAND SEDIMENT. RATE TUBE | Cordis Corp. | Jan 21, 1983 | SESE |
| K823368 | DADE ESR KIT | American Dade | Dec 28, 1982 | SESE |
Top Applicants
- Ulster Scientific, Inc. — 3 clearances
- American Dade — 1 clearance
- Cordis Corp. — 1 clearance
- Microwave Development, Inc. — 1 clearance
- Precision Technology, Inc. — 1 clearance
