JPH
7 FDA 510(k) clearances · Product code
31 daysmedian time to decision
48 days90th percentile
7clearances measured
FDA profile
- Official device name
- Test, Erythrocyte Sedimentation Rate
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.6700
- Medical specialty
- Hematology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WINPETTE (K871076) | Ulster Scientific, Inc. | 1987-03-23 |
| DISPETTE II (K860899) | Ulster Scientific, Inc. | 1986-04-14 |
| SRT-SYSTEM (K852554) | Microwave Development, Inc. | 1985-07-18 |
| SEDIPLAST (K840500) | Precision Technology, Inc. | 1984-02-21 |
| WESTERGREN DISPETTE FOR ESR (K831195) | Ulster Scientific, Inc. | 1983-05-09 |
| ERYTHROCYTE & STAND SEDIMENT. RATE TUBE (K823761) | Cordis Corp. | 1983-01-21 |
| DADE ESR KIT (K823368) | American Dade | 1982-12-28 |
Track JPH automatically
Every clearance here is in the API, with alerts when new ones post.