FDA product code DNK: Thin Layer Chromatography, Morphine
DNK is the FDA product code for thin layer chromatography, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel. FDA has cleared 4 510(k) submissions under DNK, from 4 different applicants. The average 510(k) review took 105 days (median 88).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Morphine |
| Device class | Class II |
| Regulation | 21 CFR 862.3640 |
| 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 DNK clearance
Top DNK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nantong Egens Biotech Co., Ltd. | 1 | 2015-07-16 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 2015-04-07 |
| Teco Diagnostics | 1 | 1997-07-03 |
| Medical Diagnostics, Ca. | 1 | 1986-03-03 |
Most recent DNK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K151557 | Nantong Egens Biotech Co., Ltd. | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | 2015-07-16 | 36 |
| K150602 | Guangzhou Wondfo Biotech Co., Ltd. | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | 2015-04-07 | 28 |
| K970579 | Teco Diagnostics | ONE STEP MORPHINE CARD TEST | 1997-07-03 | 139 |
| K853140 | Medical Diagnostics, Ca. | MDI QUIK TEST NARCOTICS DRUG SCREEN | 1986-03-03 | 217 |
Recalls for DNK devices
openFDA lists no recalls for product code DNK.
Frequently asked questions
What is FDA product code DNK?
DNK is the FDA product code for thin layer chromatography, morphine. It is a Class II device, regulated under 21 CFR 862.3640 and reviewed by the Clinical Toxicology panel.
What device class is DNK?
Class II, regulation 21 CFR 862.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code DNK?
Across 4 cleared submissions the average was 105 days from receipt to decision (median 88).
Which companies have the most DNK clearances?
Nantong Egens Biotech Co., Ltd. (1); Guangzhou Wondfo Biotech Co., Ltd. (1); Teco Diagnostics (1); Medical Diagnostics, Ca. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DNK
- Run a recall and safety report across every DNK manufacturer
- Watch product code DNK 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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