DKC · Class I · 21 CFR 862.3280

FDA Product Code DKC: Alcohol Control Materials

Leading manufacturers include Syva Co., Cala Diagnostics and Sigma Diagnostics, Inc..

11
Total
11
Cleared
52d
Avg days
1980
Since

FDA 510(k) Cleared Alcohol Control Materials Devices (Product Code DKC)

11 devices
1–11 of 11
Cleared Jul 01, 2003
MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
K031392
Medical Analysis Systems, Inc.
Toxicology · 60d
Cleared Mar 22, 1994
QUALITY CONTROL MATERIAL (ASSAYED)
K935819
Columbia Diagnostics, Inc.
Toxicology · 109d
Cleared Nov 16, 1993
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
K933425
Sigma Diagnostics, Inc.
Chemistry · 126d
Cleared Oct 27, 1993
BECKMAN CX AMMONIA/ALCOHOL CONTROL
K934467
Beckman-Diagnostic Systems Group
Toxicology · 47d
Cleared Jun 16, 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
K932067
Sigma Diagnostics, Inc.
Toxicology · 48d
Cleared Aug 12, 1991
SERUM ALCOHOL CONTROL LEVELS 1, 2 & 3
K912827
Cala Diagnostics
Chemistry · 47d
Cleared Jul 26, 1991
WHOLE BLOOD ALCOHOL CONTROL, LEVEL 1 & 2
K912826
Cala Diagnostics
Chemistry · 30d
Cleared Oct 31, 1984
ETHANOL CONTROLS LOW & HIGH E5133/E5258
K843872
Sigma Chemical Co.
Chemistry · 29d
Cleared Dec 08, 1983
TOXI CHEM SERUM ALCOHOL CONTROL
K833514
Fisher Diagnostics
Toxicology · 58d
Cleared Mar 06, 1981
EMIT-ST ETHYL ALCOHOL SERUM CONTROLS
K810465
Syva Co.
Toxicology · 11d
Cleared Oct 31, 1980
EMIT-STM ETHYL ALCOHOL URINE CONTROLS
K802618
Syva Co.
Toxicology · 11d

About Product Code DKC - Regulatory Context