DKC · Class I · 21 CFR 862.3280

FDA Product Code DKC: Alcohol Control Materials

Leading manufacturers include Syva Co., Sigma Diagnostics, Inc. and Medical Analysis Systems, 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 Nov 16, 1993
AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812
K933425
Sigma Diagnostics, Inc.
Chemistry · 126d
Cleared Jun 16, 1993
ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III
K932067
Sigma Diagnostics, Inc.
Toxicology · 48d
Cleared Oct 31, 1984
ETHANOL CONTROLS LOW & HIGH E5133/E5258
K843872
Sigma Chemical Co.
Chemistry · 29d
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