MKU · Class I · 21 CFR 862.3220

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

Leading manufacturers include Lin-Zhi International, Inc..

1
Total
1
Cleared
90d
Avg days
2019
Since

List of Enzyme Immunoassay, Nicotine And Nicotine Metabolites devices cleared through 510(k)

1 devices
1–1 of 1
Cleared Nov 21, 2019
LZI Cotinine II Enzyme Immunoassay
K192299
Lin-Zhi International, Inc.
Toxicology · 90d

How to use this database

This page lists all FDA 510(k) submissions for Enzyme Immunoassay, Nicotine And Nicotine Metabolites devices (product code MKU). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Toxicology FDA review panel. Browse all Toxicology devices →