FDA product code DKX: Thin Layer Chromatography, Barbiturate
DKX is the FDA product code for thin layer chromatography, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under DKX, from 2 different applicants. The average 510(k) review took 82 days (median 82).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Barbiturate |
| Device class | Class II |
| Regulation | 21 CFR 862.3150 |
| 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 DKX clearance
Top DKX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Icn Biomedicals, Inc. | 1 | 2003-06-13 |
| Hoffrel Instruments, Inc. | 1 | 1980-03-12 |
Most recent DKX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K030211 | Icn Biomedicals, Inc. | RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 | 2003-06-13 | 143 |
| K800364 | Hoffrel Instruments, Inc. | ULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202 | 1980-03-12 | 21 |
Recalls for DKX devices
openFDA lists no recalls for product code DKX.
Frequently asked questions
What is FDA product code DKX?
DKX is the FDA product code for thin layer chromatography, barbiturate. It is a Class II device, regulated under 21 CFR 862.3150 and reviewed by the Clinical Toxicology panel.
What device class is DKX?
Class II, regulation 21 CFR 862.3150. Typical premarket route: 510(k).
How long does a 510(k) take for product code DKX?
Across 2 cleared submissions the average was 82 days from receipt to decision (median 82).
Which companies have the most DKX clearances?
Icn Biomedicals, Inc. (1); Hoffrel Instruments, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DKX
- Run a recall and safety report across every DKX manufacturer
- Watch product code DKX 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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