FDA product code JFR: Indirect Copper Assay, Ceruloplasmin
JFR is the FDA product code for indirect copper assay, ceruloplasmin. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel. FDA has cleared 2 510(k) submissions under JFR, from 2 different applicants. The average 510(k) review took 78 days (median 78).
Classification
| Field | Value |
|---|---|
| Device name | Indirect Copper Assay, Ceruloplasmin |
| Device class | Class II |
| Regulation | 21 CFR 866.5210 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JFR clearance
Top JFR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sentinel Ch. Srl | 1 | 2005-10-21 |
| Technicon Instruments Corp. | 1 | 1988-07-08 |
Most recent JFR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K051456 | Sentinel Ch. Srl | SENTINEL CERULOPLASMIN | 2005-10-21 | 141 |
| K882622 | Technicon Instruments Corp. | CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM | 1988-07-08 | 14 |
Recalls for JFR devices
openFDA lists no recalls for product code JFR.
Frequently asked questions
What is FDA product code JFR?
JFR is the FDA product code for indirect copper assay, ceruloplasmin. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel.
What device class is JFR?
Class II, regulation 21 CFR 866.5210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JFR?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most JFR clearances?
Sentinel Ch. Srl (1); Technicon Instruments Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JFR
- Run a recall and safety report across every JFR manufacturer
- Watch product code JFR 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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