FDA 510(k) Applications for Medical Device Product Code "MKU"
|
FDA 510(k) Number | Applicant | Device Name | Decision Date |
K021944 | COZART BIOSCIENCE LTD. | COZART EIA COTININE URINE KIT | 05/14/2003 |
K192299 | Lin-Zhi International, Inc. | LZI Cotinine II Enzyme Immunoassay | 11/21/2019 |
K972481 | ORASURE TECHNOLOGIES, INC. | AUTO-LYTE COTININE EIA | 10/21/1997 |
K974234 | ORASURE TECHNOLOGIES, INC. | MICRO-PLATE COTININE EIA | 05/14/1998 |
K974534 | ORASURE TECHNOLOGIES, INC. | MICRO-PLATE COTININE EIA | 05/18/1998 |
K062565 | PRINCETON BIOMEDITECH CORP. | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | 02/20/2007 |
K192517 | Psychemedics Corporation | Psychemedics Microplate EIA for Cotinine in Hair | 04/22/2020 |