FDA product code CJY: Azo Dye, Calcium
CJY is the FDA product code for azo dye, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. FDA has cleared 47 510(k) submissions under CJY, 1 in the last five years, from 37 different applicants. The average 510(k) review took 84 days (median 63); 42 days on average over the last three years. FDA has posted 10 recalls for CJY devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Azo Dye, Calcium |
| Device class | Class II |
| Regulation | 21 CFR 862.1145 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CJY
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 85 |
| 2019 | 1 | 63 |
| 2025 | 1 | 42 |
Compare with all 510(k) review times · Search every CJY clearance
Top CJY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Harleco | 4 | 1981-11-10 |
| HORIBA ABX SAS | 2 | 2019-07-26 |
| Randox Laboratories, Ltd. | 2 | 2018-10-23 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 2007-09-24 |
| Abbott Laboratories | 2 | 2006-11-22 |
32 more applicants have CJY clearances. See the full list in Caduvo.
Most recent CJY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K244042 | Abbott Ireland | Calcium2 | 2025-02-10 | 42 |
| K191396 | HORIBA ABX SAS | Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe | 2019-07-26 | 63 |
| K182042 | Randox Laboratories, Ltd. | Randox Calcium (Ca) | 2018-10-23 | 85 |
| K151113 | Elitechgroup | ELITech Clinical Systems CALCIUM ARSENAZO | 2015-07-22 | 86 |
| K123171 | HORIBA ABX SAS | ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT | 2013-07-03 | 267 |
Recalls for CJY devices
10 product recalls in 8 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2025-07-09.
| Year | Recalls |
|---|---|
| 2018 | 2 |
| 2022 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code CJY?
CJY is the FDA product code for azo dye, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is CJY?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJY?
Across 47 cleared submissions the average was 84 days from receipt to decision (median 63).
Which companies have the most CJY clearances?
Harleco (4); HORIBA ABX SAS (2); Randox Laboratories, Ltd. (2); Ortho-Clinical Diagnostics, Inc. (2); Abbott Laboratories (2).
Have CJY devices been recalled?
Yes: 10 product recalls across 8 recall events; the most recent began 2025-07-09.
Next steps
- Run an FDA pathway report with predicate devices for product code CJY
- Run a recall and safety report across every CJY manufacturer
- Watch product code CJY 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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