Product code MKU— Clinical Toxicology
MICRO-PLATE COTININE EIA
- Classification name
- Enzyme Immunoassay, Nicotine And Nicotine Metabolites
- Device class
- Class 1
- Regulation
- 21 CFR 862.3220
- Advisory panel
- Clinical Toxicology
- Total cleared
- 7
- First cleared
- Most recent
Market context for product code MKU
FDA has cleared devices under product code MKU between 1997 and 2020, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2020
- 2019
- 2007
- 2003
- 1998
- 1997
Top applicants under product code MKU
Recent clearances under product code MKU
- K192517 — Psychemedics Microplate EIA for Cotinine in Hair
- K192299 — LZI Cotinine II Enzyme Immunoassay
- K062565 — STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
- K021944 — COZART EIA COTININE URINE KIT
- K974534 — MICRO-PLATE COTININE EIA
- K974234 — MICRO-PLATE COTININE EIA
- K972481 — AUTO-LYTE COTININE EIA
Data sourced from openFDA. This site is unofficial and independent of the FDA.