FDA product code JPC: Hemoglobin F Quantitation
JPC is the FDA product code for hemoglobin f quantitation. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under JPC. The average 510(k) review took 109 days (median 109).
Classification
| Field | Value |
|---|---|
| Device name | Hemoglobin F Quantitation |
| Device class | Class II |
| Regulation | 21 CFR 864.7455 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top JPC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Isolab, Inc. | 1 | 1982-06-25 |
Most recent JPC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K820630 | Isolab, Inc. | QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL | 1982-06-25 | 109 |
Recalls for JPC devices
openFDA lists no recalls for product code JPC.
Frequently asked questions
What is FDA product code JPC?
JPC is the FDA product code for hemoglobin f quantitation. It is a Class II device, regulated under 21 CFR 864.7455 and reviewed by the Hematology panel.
What device class is JPC?
Class II, regulation 21 CFR 864.7455. Typical premarket route: 510(k).
How long does a 510(k) take for product code JPC?
Across 1 cleared submissions the average was 109 days from receipt to decision (median 109).
Which companies have the most JPC clearances?
Isolab, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JPC
- Run a recall and safety report across every JPC manufacturer
- Watch product code JPC 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.