Atlas FDA

MRS

3 FDA 510(k) clearances · Product code

FDA profile

Official device name
Test System, Nicotine, Cotinine, Metabolites
Device class
Class I (low risk)
Regulation
21 CFR 862.3220
Medical specialty
Clinical Toxicology
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RecordFirmDate
DRI COTININE EIA ASSAY (K030649)Microgenics Corp.2003-05-22
NICALERT (K021688)Nymox Pharmaceutical Corporation2002-10-18
NICCHECK I (K963733)Dynagen, Inc.1996-12-13

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Every clearance here is in the API, with alerts when new ones post.