FDA product code DKJ: Colorimetry, Salicylate
DKJ is the FDA product code for colorimetry, salicylate. It is a Class II device, regulated under 21 CFR 862.3830 and reviewed by the Clinical Toxicology panel. FDA has cleared 29 510(k) submissions under DKJ, from 23 different applicants. The average 510(k) review took 66 days (median 56). FDA has posted 6 recalls for DKJ devices.
Classification
| Field | Value |
|---|---|
| Device name | Colorimetry, Salicylate |
| Device class | Class II |
| Regulation | 21 CFR 862.3830 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every DKJ clearance
Top DKJ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Chemicals , Ltd. | 3 | 2004-12-27 |
| Em Diagnostic Systems, Inc. | 3 | 1987-10-29 |
| Abbott Laboratories | 2 | 1995-08-08 |
| Diagnostic Chemicals, Ltd. (Usa) | 2 | 1987-02-20 |
| Siemens Healthcare Diagnostics | 1 | 2010-05-19 |
18 more applicants have DKJ clearances. See the full list in Caduvo.
Most recent DKJ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K093939 | Siemens Healthcare Diagnostics | ADVIA CHEMISTRY SALICYLATE REAGENT | 2010-05-19 | 148 |
| K042329 | Diagnostic Chemicals , Ltd. | SALICYLATE-SL ASSAY | 2004-12-27 | 122 |
| K020794 | Bayer Diagnostics Corp. | SALICYLATE ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | 2002-07-11 | 122 |
| K014173 | Beckman Coulter, Inc. | SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR | 2002-02-15 | 57 |
| K011878 | Syva Co. | EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL | 2001-08-13 | 59 |
Recalls for DKJ devices
6 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-06-29.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code DKJ?
DKJ is the FDA product code for colorimetry, salicylate. It is a Class II device, regulated under 21 CFR 862.3830 and reviewed by the Clinical Toxicology panel.
What device class is DKJ?
Class II, regulation 21 CFR 862.3830. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKJ?
Across 29 cleared submissions the average was 66 days from receipt to decision (median 56).
Which companies have the most DKJ clearances?
Diagnostic Chemicals , Ltd. (3); Em Diagnostic Systems, Inc. (3); Abbott Laboratories (2); Diagnostic Chemicals, Ltd. (Usa) (2); Siemens Healthcare Diagnostics (1).
Have DKJ devices been recalled?
Yes: 6 product recalls across 6 recall events; the most recent began 2017-06-29.
Next steps
- Run an FDA pathway report with predicate devices for product code DKJ
- Run a recall and safety report across every DKJ manufacturer
- Watch product code DKJ 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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