FDA product code CHN: Immunochemical, Ceruloplasmin
CHN is the FDA product code for immunochemical, ceruloplasmin. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel. FDA has cleared 3 510(k) submissions under CHN, from 3 different applicants. The average 510(k) review took 178 days (median 191). FDA has posted 6 recalls for CHN devices.
Classification
| Field | Value |
|---|---|
| Device name | Immunochemical, 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 CHN clearance
Top CHN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Diagnostics | 1 | 2010-03-18 |
| Dade Behring, Inc. | 1 | 2007-02-15 |
| Roche Diagnostics Corp. | 1 | 2007-01-31 |
Most recent CHN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091741 | Roche Diagnostics | TINA-QUANT CERULOPLASMIN | 2010-03-18 | 275 |
| K063655 | Dade Behring, Inc. | DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH | 2007-02-15 | 69 |
| K062114 | Roche Diagnostics Corp. | CERULOPLASMIN, MODEL 2055953 | 2007-01-31 | 191 |
Recalls for CHN devices
6 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-05.
| Year | Recalls |
|---|---|
| 2017 | 6 |
Frequently asked questions
What is FDA product code CHN?
CHN is the FDA product code for immunochemical, ceruloplasmin. It is a Class II device, regulated under 21 CFR 866.5210 and reviewed by the Immunology panel.
What device class is CHN?
Class II, regulation 21 CFR 866.5210. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CHN?
Across 3 cleared submissions the average was 178 days from receipt to decision (median 191).
Which companies have the most CHN clearances?
Roche Diagnostics (1); Dade Behring, Inc. (1); Roche Diagnostics Corp. (1).
Have CHN devices been recalled?
Yes: 6 product recalls across 2 recall events; the most recent began 2017-06-05.
Next steps
- Run an FDA pathway report with predicate devices for product code CHN
- Run a recall and safety report across every CHN manufacturer
- Watch product code CHN 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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