MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites Class I
FDA product code MKU covers "Enzyme Immunoassay, Nicotine And Nicotine Metabolites", a Class I medical device regulated under 21 CFR 862.3220. Submissions are reviewed by the Clinical Toxicology panel. At least 7 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K192517 | psychemedics corporation | Psychemedics Microplate EIA for Cotinine in Hair | April 22, 2020 |
| K192299 | lin-zhi international | LZI Cotinine II Enzyme Immunoassay | November 21, 2019 |
| K062565 | princeton biomeditech | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | February 20, 2007 |
| K021944 | cozart bioscience | COZART EIA COTININE URINE KIT | May 14, 2003 |
| K974534 | orasure technologies | MICRO-PLATE COTININE EIA | May 18, 1998 |
| K974234 | orasure technologies | MICRO-PLATE COTININE EIA | May 14, 1998 |
| K972481 | orasure technologies | AUTO-LYTE COTININE EIA | October 21, 1997 |