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MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites Class I

FDA Device Classification

Classification Details

Product Code
MKU
Device Class
Class I
Regulation Number
862.3220
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K192517psychemedics corporationPsychemedics Microplate EIA for Cotinine in HairApril 22, 2020
K192299lin-zhi internationalLZI Cotinine II Enzyme ImmunoassayNovember 21, 2019
K062565princeton biomeditechSTATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINEFebruary 20, 2007
K021944cozart bioscienceCOZART EIA COTININE URINE KITMay 14, 2003
K974534orasure technologiesMICRO-PLATE COTININE EIAMay 18, 1998
K974234orasure technologiesMICRO-PLATE COTININE EIAMay 14, 1998
K972481orasure technologiesAUTO-LYTE COTININE EIAOctober 21, 1997