FDA product code DMT: Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet
DMT is the FDA product code for enzymatic method, alcohol dehydrogenase, ultraviolet. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel. FDA has cleared 8 510(k) submissions under DMT, from 7 different applicants. The average 510(k) review took 68 days (median 32). FDA has posted 1 recall for DMT devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet |
| Device class | Class II |
| Regulation | 21 CFR 862.3040 |
| 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 DMT clearance
Top DMT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 2 | 1981-03-06 |
| Beckman Coulter, Inc. | 1 | 2000-04-10 |
| Beckman Instruments, Inc. | 1 | 1997-06-03 |
| Eastman Kodak Company | 1 | 1994-03-21 |
| Diagnostic Reagents, Inc. | 1 | 1993-01-21 |
2 more applicants have DMT clearances. See the full list in Caduvo.
Most recent DMT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000410 | Beckman Coulter, Inc. | SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS | 2000-04-10 | 62 |
| K971506 | Beckman Instruments, Inc. | SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR | 1997-06-03 | 39 |
| K934273 | Eastman Kodak Company | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) | 1994-03-21 | 202 |
| K923783 | Diagnostic Reagents, Inc. | ETHYL ALCOHOL ASSAY | 1993-01-21 | 177 |
| K864894 | Em Diagnostic Systems, Inc. | EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 | 1987-01-09 | 25 |
Recalls for DMT devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-06-12.
Frequently asked questions
What is FDA product code DMT?
DMT is the FDA product code for enzymatic method, alcohol dehydrogenase, ultraviolet. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel.
What device class is DMT?
Class II, regulation 21 CFR 862.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code DMT?
Across 8 cleared submissions the average was 68 days from receipt to decision (median 32).
Which companies have the most DMT clearances?
Syva Co. (2); Beckman Coulter, Inc. (1); Beckman Instruments, Inc. (1); Eastman Kodak Company (1); Diagnostic Reagents, Inc. (1).
Have DMT devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2013-06-12.
Next steps
- Run an FDA pathway report with predicate devices for product code DMT
- Run a recall and safety report across every DMT manufacturer
- Watch product code DMT 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.
All Clinical Toxicology product codes · FDA product code lookup · 510(k) database search · 510(k) review times