FDA product code DCH: System, Test, C-Reactive Protein, Rhodamine
DCH is the FDA product code for system, test, c-reactive protein, rhodamine. It is a Class II device, regulated under 21 CFR 866.5270 and reviewed by the Immunology panel. FDA has cleared 1 510(k) submission under DCH. The average 510(k) review took 90 days (median 90).
Classification
| Field | Value |
|---|---|
| Device name | System, Test, C-Reactive Protein, Rhodamine |
| Device class | Class II |
| Regulation | 21 CFR 866.5270 |
| 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 DCH clearance
Top DCH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Behring Diagnostics, Inc. | 1 | 1996-12-16 |
Most recent DCH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K964687 | Behring Diagnostics, Inc. | N LATEX CRP MONO REAGENT | 1996-12-16 | 90 |
Recalls for DCH devices
openFDA lists no recalls for product code DCH.
Frequently asked questions
What is FDA product code DCH?
DCH is the FDA product code for system, test, c-reactive protein, rhodamine. It is a Class II device, regulated under 21 CFR 866.5270 and reviewed by the Immunology panel.
What device class is DCH?
Class II, regulation 21 CFR 866.5270. Typical premarket route: 510(k).
How long does a 510(k) take for product code DCH?
Across 1 cleared submissions the average was 90 days from receipt to decision (median 90).
Which companies have the most DCH clearances?
Behring Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DCH
- Run a recall and safety report across every DCH manufacturer
- Watch product code DCH 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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