DNN
7 FDA 510(k) clearances · Product code
41 daysmedian time to decision
78 days90th percentile
7clearances measured
FDA profile
- Official device name
- Calibrators, Ethyl Alcohol
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Medical specialty
- Clinical Toxicology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K990516) | Emd Chemicals, Inc. | 1999-03-31 |
| ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS (K973054) | Emd Chemicals, Inc. | 1997-10-01 |
| ETHYL ALCOHOL CALIBRATORS & CONTROL (K924733) | Diagnostic Reagents, Inc. | 1992-12-09 |
| ETHYL ALCOHOL STANDARD (K882117) | Verichem Laboratories, Inc. | 1988-08-04 |
| ALCOHOL CALIBRATORS (K853532) | Diagnostic Systems | 1985-09-16 |
| ETHYL ALCOHOL SERUM CALIBRATOR (K810466) | Syva Co. | 1981-03-06 |
| EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR (K802620) | Syva Co. | 1980-10-31 |
Track DNN automatically
Every clearance here is in the API, with alerts when new ones post.