FDA product code DNN: Calibrators, Ethyl Alcohol
DNN is the FDA product code for calibrators, ethyl alcohol. It is a Class II device, regulated under 21 CFR 862.3200 and reviewed by the Clinical Toxicology panel. FDA has cleared 7 510(k) submissions under DNN, from 5 different applicants. The average 510(k) review took 41 days (median 41). FDA has posted 2 recalls for DNN devices.
Classification
| Field | Value |
|---|---|
| Device name | Calibrators, Ethyl Alcohol |
| Device class | Class II |
| Regulation | 21 CFR 862.3200 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DNN clearance
Top DNN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Emd Chemicals, Inc. | 2 | 1999-03-31 |
| Syva Co. | 2 | 1981-03-06 |
| Diagnostic Reagents, Inc. | 1 | 1992-12-09 |
| Verichem Laboratories, Inc. | 1 | 1988-08-04 |
| Diagnostic Systems | 1 | 1985-09-16 |
Most recent DNN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K990516 | Emd Chemicals, Inc. | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | 1999-03-31 | 41 |
| K973054 | Emd Chemicals, Inc. | ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS | 1997-10-01 | 47 |
| K924733 | Diagnostic Reagents, Inc. | ETHYL ALCOHOL CALIBRATORS & CONTROL | 1992-12-09 | 78 |
| K882117 | Verichem Laboratories, Inc. | ETHYL ALCOHOL STANDARD | 1988-08-04 | 77 |
| K853532 | Diagnostic Systems | ALCOHOL CALIBRATORS | 1985-09-16 | 24 |
Recalls for DNN devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-07-26.
Frequently asked questions
What is FDA product code DNN?
DNN is the FDA product code for calibrators, ethyl alcohol. It is a Class II device, regulated under 21 CFR 862.3200 and reviewed by the Clinical Toxicology panel.
What device class is DNN?
Class II, regulation 21 CFR 862.3200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DNN?
Across 7 cleared submissions the average was 41 days from receipt to decision (median 41).
Which companies have the most DNN clearances?
Emd Chemicals, Inc. (2); Syva Co. (2); Diagnostic Reagents, Inc. (1); Verichem Laboratories, Inc. (1); Diagnostic Systems (1).
Have DNN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2010-07-26.
Next steps
- Run an FDA pathway report with predicate devices for product code DNN
- Run a recall and safety report across every DNN manufacturer
- Watch product code DNN 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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