FDA product code MLK: Thin Layer Chromatography, Tricyclic Antidepressant Drugs
MLK is the FDA product code for thin layer chromatography, tricyclic antidepressant drugs. It is a Class II device, regulated under 21 CFR 862.3910 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under MLK, from 2 different applicants. The average 510(k) review took 129 days (median 129).
Classification
| Field | Value |
|---|---|
| Device name | Thin Layer Chromatography, Tricyclic Antidepressant Drugs |
| Device class | Class II |
| Regulation | 21 CFR 862.3910 |
| 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 MLK clearance
Top MLK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Alfa Scientific Designs, Inc. | 1 | 2002-12-09 |
| Branan Medical Corp. | 1 | 2001-07-30 |
Most recent MLK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022693 | Alfa Scientific Designs, Inc. | INSTANT-VIEW TCA URINE TEST | 2002-12-09 | 118 |
| K010734 | Branan Medical Corp. | BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21 | 2001-07-30 | 140 |
Recalls for MLK devices
openFDA lists no recalls for product code MLK.
Frequently asked questions
What is FDA product code MLK?
MLK is the FDA product code for thin layer chromatography, tricyclic antidepressant drugs. It is a Class II device, regulated under 21 CFR 862.3910 and reviewed by the Clinical Toxicology panel.
What device class is MLK?
Class II, regulation 21 CFR 862.3910. Typical premarket route: 510(k).
How long does a 510(k) take for product code MLK?
Across 2 cleared submissions the average was 129 days from receipt to decision (median 129).
Which companies have the most MLK clearances?
Alfa Scientific Designs, Inc. (1); Branan Medical Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MLK
- Run a recall and safety report across every MLK manufacturer
- Watch product code MLK 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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