FDA product code DML: Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
DML is the FDA product code for nad-nadh, specific reagent for alcohol enzyme method. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel. FDA has cleared 13 510(k) submissions under DML, from 10 different applicants. The average 510(k) review took 65 days (median 62). FDA has posted 1 recall for DML devices.
Classification
| Field | Value |
|---|---|
| Device name | Nad-Nadh, Specific Reagent For Alcohol Enzyme Method |
| 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 DML clearance
Top DML applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 3 | 2000-02-01 |
| Abbott Laboratories | 2 | 2001-12-14 |
| Ansys, Inc. | 1 | 1996-09-19 |
| Boehringer Mannheim Corp. | 1 | 1995-08-24 |
| Toxi-Lab, Inc. | 1 | 1993-01-12 |
5 more applicants have DML clearances. See the full list in Caduvo.
Most recent DML clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K013538 | Abbott Laboratories | ETHANOL | 2001-12-14 | 51 |
| K993980 | Syva Co. | SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL | 2000-02-01 | 69 |
| K963197 | Ansys, Inc. | ON.SITE ALCOHOL | 1996-09-19 | 35 |
| K953765 | Abbott Laboratories | AXSYM REA ETHANOL | 1995-09-27 | 47 |
| K952839 | Boehringer Mannheim Corp. | BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY | 1995-08-24 | 64 |
Recalls for DML devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-07-18.
Frequently asked questions
What is FDA product code DML?
DML is the FDA product code for nad-nadh, specific reagent for alcohol enzyme method. It is a Class II device, regulated under 21 CFR 862.3040 and reviewed by the Clinical Toxicology panel.
What device class is DML?
Class II, regulation 21 CFR 862.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code DML?
Across 13 cleared submissions the average was 65 days from receipt to decision (median 62).
Which companies have the most DML clearances?
Syva Co. (3); Abbott Laboratories (2); Ansys, Inc. (1); Boehringer Mannheim Corp. (1); Toxi-Lab, Inc. (1).
Have DML devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2003-07-18.
Next steps
- Run an FDA pathway report with predicate devices for product code DML
- Run a recall and safety report across every DML manufacturer
- Watch product code DML 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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