FDA product code JNM: Immunochemical, Transferrin
JNM is the FDA product code for immunochemical, transferrin. It is a Class II device, regulated under 21 CFR 866.5880 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under JNM, from 3 different applicants. The average 510(k) review took 151 days (median 160). FDA has posted 3 recalls for JNM devices.
Classification
| Field | Value |
|---|---|
| Device name | Immunochemical, Transferrin |
| Device class | Class II |
| Regulation | 21 CFR 866.5880 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JNM clearance
Top JNM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nichols Institute Diagnostics | 1 | 1999-12-06 |
| Ramco Laboratories, Inc. | 1 | 1998-10-21 |
| R&D Systems, Inc. | 1 | 1997-05-27 |
Most recent JNM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992188 | Nichols Institute Diagnostics | NICHOLS ADVANTAGE CHEMILUMINESCENCE SOLUBLE TRANSFERRIN RECEPTOR IMMUNOASSAY, MODEL 62-7028 | 1999-12-06 | 160 |
| K981208 | Ramco Laboratories, Inc. | TFR | 1998-10-21 | 202 |
| K970718 | R&D Systems, Inc. | QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) | 1997-05-27 | 90 |
Recalls for JNM devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-01-20.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2021 | 1 |
Frequently asked questions
What is FDA product code JNM?
JNM is the FDA product code for immunochemical, transferrin. It is a Class II device, regulated under 21 CFR 866.5880 and reviewed by the Immunology panel.
What device class is JNM?
Class II, regulation 21 CFR 866.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code JNM?
Across 3 cleared submissions the average was 151 days from receipt to decision (median 160).
Which companies have the most JNM clearances?
Nichols Institute Diagnostics (1); Ramco Laboratories, Inc. (1); R&D Systems, Inc. (1).
Have JNM devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2021-01-20.
Next steps
- Run an FDA pathway report with predicate devices for product code JNM
- Run a recall and safety report across every JNM manufacturer
- Watch product code JNM 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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