MKU · Class I · 21 CFR 862.3220

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

Leading manufacturers include Lin-Zhi International, Inc. and Psychemedics Corporation.

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

About Product Code MKU - Regulatory Context