DKC
11 FDA 510(k) clearances · Product code
47 daysmedian time to decision
109 days90th percentile
11clearances measured
FDA profile
- Official device name
- Alcohol Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Medical specialty
- Clinical Toxicology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL (K031392) | Medical Analysis Systems, Inc. | 2003-07-01 |
| QUALITY CONTROL MATERIAL (ASSAYED) (K935819) | Columbia Diagnostics, Inc. | 1994-03-22 |
| AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 (K933425) | Sigma Diagnostics, Inc. | 1993-11-16 |
| BECKMAN CX AMMONIA/ALCOHOL CONTROL (K934467) | Beckman-Diagnostic Systems Group | 1993-10-27 |
| ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III (K932067) | Sigma Diagnostics, Inc. | 1993-06-16 |
| SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3 (K912827) | Cala Diagnostics | 1991-08-12 |
| WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2 (K912826) | Cala Diagnostics | 1991-07-26 |
| ETHANOL CONTROLS LOW & HIGH E5133/E5258 (K843872) | Sigma Chemical Co. | 1984-10-31 |
| TOXI CHEM SERUM ALCOHOL CONTROL (K833514) | Fisher Diagnostics | 1983-12-08 |
| EMIT-ST ETHYL ALCOHOL SERUM CONTROLS (K810465) | Syva Co. | 1981-03-06 |
| EMIT-STM ETHYL ALCOHOL URINE CONTROLS (K802618) | Syva Co. | 1980-10-31 |
Track DKC automatically
Every clearance here is in the API, with alerts when new ones post.