FDA product code DCK: C-Reactive Protein, Antigen, Antiserum, And Control
DCK is the FDA product code for c-reactive protein, antigen, antiserum, and control. It is a Class II device, regulated under 21 CFR 866.5270 and reviewed by the Immunology panel. FDA has cleared 126 510(k) submissions under DCK, 2 in the last five years, from 76 different applicants. The average 510(k) review took 94 days (median 63); 268 days on average over the last three years. FDA has posted 17 recalls for DCK devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | C-Reactive Protein, Antigen, Antiserum, And Control |
| 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 |
510(k) clearances per year for DCK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 486 |
| 2019 | 2 | 82 |
| 2020 | 1 | 335 |
| 2022 | 1 | 907 |
| 2025 | 1 | 268 |
Compare with all 510(k) review times · Search every DCK clearance
Top DCK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kamiya Biomedical Co. | 8 | 2003-02-04 |
| E.I. Dupont DE Nemours & Co., Inc. | 5 | 1988-10-19 |
| Syva Co. | 5 | 1982-12-09 |
| Beckman Coulter, Inc. | 4 | 2001-05-29 |
| Beckman Instruments, Inc. | 4 | 1997-11-24 |
71 more applicants have DCK clearances. See the full list in Caduvo.
Most recent DCK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242170 | Kamiya Biomedical Company, LLC | K-ASSAY CRP (Ver.2) | 2025-04-18 | 268 |
| K201256 | Procise Diagnostics | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge | 2022-11-04 | 907 |
| K192028 | HORIBA ABX SAS | Yumizen C1200 CRP | 2020-06-25 | 335 |
| K192118 | SENTINEL CH. SpA | CRP Vario | 2019-11-08 | 94 |
| K191993 | HORIBA ABX SAS | Yumizen C1200 CRP | 2019-10-03 | 70 |
Recalls for DCK devices
17 product recalls in 16 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-04-14.
| Year | Recalls |
|---|---|
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code DCK?
DCK is the FDA product code for c-reactive protein, antigen, antiserum, and control. It is a Class II device, regulated under 21 CFR 866.5270 and reviewed by the Immunology panel.
What device class is DCK?
Class II, regulation 21 CFR 866.5270. Typical premarket route: 510(k).
How long does a 510(k) take for product code DCK?
Across 126 cleared submissions the average was 94 days from receipt to decision (median 63).
Which companies have the most DCK clearances?
Kamiya Biomedical Co. (8); E.I. Dupont DE Nemours & Co., Inc. (5); Syva Co. (5); Beckman Coulter, Inc. (4); Beckman Instruments, Inc. (4).
Have DCK devices been recalled?
Yes: 17 product recalls across 16 recall events; the most recent began 2025-04-14.
Next steps
- Run an FDA pathway report with predicate devices for product code DCK
- Run a recall and safety report across every DCK manufacturer
- Watch product code DCK 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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