MKU · Class I · 21 CFR 862.3220

FDA Product Code MKU: Enzyme Immunoassay, Nicotine And Nicotine Metabolites

Leading manufacturers include OraSure Technologies, Inc., Cozart Bioscience , Ltd. and Princeton BioMeditech Corp..

7
Total
7
Cleared
183d
Avg days
1997
Since

FDA 510(k) Cleared Enzyme Immunoassay, Nicotine And Nicotine Metabolites Devices (Product Code MKU)

7 devices
1–7 of 7
Cleared Apr 22, 2020
Psychemedics Microplate EIA for Cotinine in Hair
K192517
Psychemedics Corporation
Toxicology · 222d
Cleared Nov 21, 2019
LZI Cotinine II Enzyme Immunoassay
K192299
Lin-Zhi International, Inc.
Toxicology · 90d
Cleared Feb 20, 2007
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
K062565
Princeton BioMeditech Corp.
Chemistry · 173d
Cleared May 14, 2003
COZART EIA COTININE URINE KIT
K021944
Cozart Bioscience , Ltd.
Toxicology · 335d
Cleared May 18, 1998
MICRO-PLATE COTININE EIA
K974534
OraSure Technologies, Inc.
Toxicology · 167d
Cleared May 14, 1998
MICRO-PLATE COTININE EIA
K974234
OraSure Technologies, Inc.
Toxicology · 183d
Cleared Oct 21, 1997
AUTO-LYTE COTININE EIA
K972481
OraSure Technologies, Inc.
Toxicology · 111d

About Product Code MKU - Regulatory Context