Product code DKC— Clinical Toxicology
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
- Classification name
- Alcohol Control Materials
- Device class
- Class 1
- Regulation
- 21 CFR 862.3280
- Advisory panel
- Clinical Toxicology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code DKC
FDA has cleared devices under product code DKC between 1980 and 2003, filed by 8 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2003
- 1994
- 1993
- 1991
- 1984
- 1983
- 1981
- 1980
Top applicants under product code DKC
Recent clearances under product code DKC
- K031392 — MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
- K935819 — QUALITY CONTROL MATERIAL (ASSAYED)
- K933425 — AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
- K934467 — BECKMAN CX AMMONIA/ALCOHOL CONTROL
- K932067 — ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
- K912827 — SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
- K912826 — WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
- K843872 — ETHANOL CONTROLS LOW & HIGH E5133/E5258
- K833514 — TOXI CHEM SERUM ALCOHOL CONTROL
- K810465 — EMIT-ST ETHYL ALCOHOL SERUM CONTROLS
- K802618 — EMIT-STM ETHYL ALCOHOL URINE CONTROLS
Data sourced from openFDA. This site is unofficial and independent of the FDA.