DML
13 FDA 510(k) clearances · Product code
62 daysmedian time to decision
77 days90th percentile
13clearances measured
FDA profile
- Official device name
- Nad-Nadh, Specific Reagent For Alcohol Enzyme Method
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3040
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2002: 1 · 2005: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ETHANOL (K013538) | Abbott Laboratories | 2001-12-14 |
| SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL (K993980) | Syva Co. | 2000-02-01 |
| ON.SITE ALCOHOL (K963197) | Ansys, Inc. | 1996-09-19 |
| AXSYM REA ETHANOL (K953765) | Abbott Laboratories | 1995-09-27 |
| BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY (K952839) | Boehringer Mannheim Corp. | 1995-08-24 |
| ON*SITE ALCOHOL (K923337) | Toxi-Lab, Inc. | 1993-01-12 |
| SIGMA PROCEDURE NO. 333-UV (K914777) | Sigma Diagnostics, Inc. | 1991-12-27 |
| RAICHEM(TM) ALCOHOL REAGENT (K874382) | Reagents Applications, Inc. | 1988-01-11 |
| KINETIC 610 ETHANOL (K872180) | American Monitor Corp. | 1987-07-07 |
| EMDS(TM) ALCOHOL TESTPACKS, #67691/95 (K863419) | Em Diagnostic Systems, Inc. | 1986-09-29 |
| PARAMAX ALCOHOL REAGENT (K840769) | American Dade | 1984-04-13 |
| EMIT ST SERUM ETHYL ALCOHOL ASSAY (K840400) | Syva Co. | 1984-03-23 |
| EMIT ST URINE ETHYL ALCOHOL ASSAY (K840171) | Syva Co. | 1984-03-19 |
Track DML automatically
Every clearance here is in the API, with alerts when new ones post.