FDA product code JPH: Test, Erythrocyte Sedimentation Rate
JPH is the FDA product code for test, erythrocyte sedimentation rate. It is a Class I device, regulated under 21 CFR 864.6700 and reviewed by the Hematology panel. FDA has cleared 7 510(k) submissions under JPH, from 5 different applicants. The average 510(k) review took 28 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Test, Erythrocyte Sedimentation Rate |
| Device class | Class I |
| Regulation | 21 CFR 864.6700 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JPH clearance
Top JPH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ulster Scientific, Inc. | 3 | 1987-03-23 |
| Microwave Development, Inc. | 1 | 1985-07-18 |
| Precision Technology, Inc. | 1 | 1984-02-21 |
| Cordis Corp. | 1 | 1983-01-21 |
| American Dade | 1 | 1982-12-28 |
Most recent JPH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K871076 | Ulster Scientific, Inc. | WINPETTE | 1987-03-23 | 5 |
| K860899 | Ulster Scientific, Inc. | DISPETTE II | 1986-04-14 | 35 |
| K852554 | Microwave Development, Inc. | SRT-SYSTEM | 1985-07-18 | 31 |
| K840500 | Precision Technology, Inc. | SEDIPLAST | 1984-02-21 | 15 |
| K831195 | Ulster Scientific, Inc. | WESTERGREN DISPETTE FOR ESR | 1983-05-09 | 27 |
Recalls for JPH devices
openFDA lists no recalls for product code JPH.
Frequently asked questions
What is FDA product code JPH?
JPH is the FDA product code for test, erythrocyte sedimentation rate. It is a Class I device, regulated under 21 CFR 864.6700 and reviewed by the Hematology panel.
What device class is JPH?
Class I, regulation 21 CFR 864.6700. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JPH?
Across 7 cleared submissions the average was 28 days from receipt to decision (median 31).
Which companies have the most JPH clearances?
Ulster Scientific, Inc. (3); Microwave Development, Inc. (1); Precision Technology, Inc. (1); Cordis Corp. (1); American Dade (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JPH
- Run a recall and safety report across every JPH manufacturer
- Watch product code JPH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Hematology product codes · FDA product code lookup · 510(k) database search · 510(k) review times