FDA product code DKG: Plate, Cellulose, Tlc
DKG is the FDA product code for plate, cellulose, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel. FDA has cleared 1 510(k) submission under DKG. The average 510(k) review took 20 days (median 20).
Classification
| Field | Value |
|---|---|
| Device name | Plate, Cellulose, Tlc |
| Device class | Class I |
| Regulation | 21 CFR 862.2270 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DKG clearance
Top DKG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 1 | 1989-08-03 |
Most recent DKG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K894327 | Syva Co. | EMIT D.A.U. LOW & MEDIUM CALIBRATOR A | 1989-08-03 | 20 |
Recalls for DKG devices
openFDA lists no recalls for product code DKG.
Frequently asked questions
What is FDA product code DKG?
DKG is the FDA product code for plate, cellulose, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel.
What device class is DKG?
Class I, regulation 21 CFR 862.2270. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DKG?
Across 1 cleared submissions the average was 20 days from receipt to decision (median 20).
Which companies have the most DKG clearances?
Syva Co. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DKG
- Run a recall and safety report across every DKG manufacturer
- Watch product code DKG 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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