FDA product code DKK: Tanks, Developing, Tlc
DKK is the FDA product code for tanks, developing, 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 DKK. The average 510(k) review took 14 days (median 14).
Classification
| Field | Value |
|---|---|
| Device name | Tanks, Developing, Tlc |
| Device class | Class I |
| Regulation | 21 CFR 862.2270 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every DKK clearance
Top DKK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marion Laboratories, Inc. | 1 | 1981-11-02 |
Most recent DKK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812919 | Marion Laboratories, Inc. | MULTI-GRAM DEVELOPING TANK R-12 & R-3 | 1981-11-02 | 14 |
Recalls for DKK devices
openFDA lists no recalls for product code DKK.
Frequently asked questions
What is FDA product code DKK?
DKK is the FDA product code for tanks, developing, tlc. It is a Class I device, regulated under 21 CFR 862.2270 and reviewed by the Clinical Toxicology panel.
What device class is DKK?
Class I, regulation 21 CFR 862.2270. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DKK?
Across 1 cleared submissions the average was 14 days from receipt to decision (median 14).
Which companies have the most DKK clearances?
Marion Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DKK
- Run a recall and safety report across every DKK manufacturer
- Watch product code DKK 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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