FDA product code JPJ: Red-Cell Indices, Calculated
JPJ is the FDA product code for red-cell indices, calculated. It is a Class II device, regulated under 21 CFR 864.5300 and reviewed by the Hematology panel. FDA has cleared 3 510(k) submissions under JPJ, from 3 different applicants. The average 510(k) review took 37 days (median 41).
Classification
| Field | Value |
|---|---|
| Device name | Red-Cell Indices, Calculated |
| Device class | Class II |
| Regulation | 21 CFR 864.5300 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JPJ clearance
Top JPJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 1990-11-02 |
| Hycel, Inc. | 1 | 1978-07-27 |
| J.T. Baker Chemical Co. | 1 | 1977-02-01 |
Most recent JPJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K904675 | Bd Becton Dickinson Vacutainer Systems Preanalytic | QBC SYSTEM MCHC | 1990-11-02 | 21 |
| K780946 | Hycel, Inc. | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | 1978-07-27 | 48 |
| K761304 | J.T. Baker Chemical Co. | JTB 700 HEMATOLOGY ANALYZER | 1977-02-01 | 41 |
Recalls for JPJ devices
openFDA lists no recalls for product code JPJ.
Frequently asked questions
What is FDA product code JPJ?
JPJ is the FDA product code for red-cell indices, calculated. It is a Class II device, regulated under 21 CFR 864.5300 and reviewed by the Hematology panel.
What device class is JPJ?
Class II, regulation 21 CFR 864.5300. Typical premarket route: 510(k).
How long does a 510(k) take for product code JPJ?
Across 3 cleared submissions the average was 37 days from receipt to decision (median 41).
Which companies have the most JPJ clearances?
Bd Becton Dickinson Vacutainer Systems Preanalytic (1); Hycel, Inc. (1); J.T. Baker Chemical Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JPJ
- Run a recall and safety report across every JPJ manufacturer
- Watch product code JPJ 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.
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