510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MKUClass I

Enzyme Immunoassay, Nicotine And Nicotine Metabolites

21 CFR 862.3220 / Clinical Toxicology
FDA source (opens on fda.gov)

MKU is the FDA product code for Enzyme Immunoassay, Nicotine And Nicotine Metabolites, a class I device type, regulated under 21 CFR 862.3220. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MKU
Device name
Enzyme Immunoassay, Nicotine And Nicotine Metabolites
Regulation
21 CFR 862.3220
Device class
Class I
Review panel
Clinical Toxicology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code MKU

By decision year
7 clearances under product code MKU with a decision year between 1997 and 2020, 1998 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code MKU by decision year
YearClearances
19971
19982
20031
20071
20191
20201

Applicants with the most clearances

Product code MKU
Applicants holding the most 510(k) clearances under product code MKU
ApplicantClearances
OraSure Technologies, Inc.3
Cozart Bioscience, Ltd.1
Lin-Zhi International Inc1
Princeton BioMeditech Corp.1
Psychemedics Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code