Product code MKU
- Device name
- Enzyme Immunoassay, Nicotine And Nicotine Metabolites
- Medical specialty
- Clinical Toxicology
- Device class
- 1
- Regulation number
- 862.3220
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | Psychemedics Corporation | 2020-04-22 |
| K192299 | LZI Cotinine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2019-11-21 |
| K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | Princeton BioMeditech Corp. | 2007-02-20 |
| K021944 | COZART EIA COTININE URINE KIT | Cozart Bioscience , Ltd. | 2003-05-14 |
| K974534 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | 1998-05-18 |
| K974234 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | 1998-05-14 |
| K972481 | AUTO-LYTE COTININE EIA | OraSure Technologies, Inc. | 1997-10-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10722066008376 | Rapid Response | BTNX Inc | 2024-08-14 |
| 00722066008379 | Rapid Response | BTNX Inc | 2024-08-14 |
| 10722066008369 | Rapid Response | BTNX Inc | 2024-02-26 |
| 00810124273309 | SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) | Alere San Diego, Inc. | 2023-12-15 |
| 10810124273306 | SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200) | ALERE SAN DIEGO, INC. | 2023-12-15 |
| B07605210 | LZI Cotinine II Enzyme Immunoassay | LIN-ZHI INTERNATIONAL, INC. | 2022-04-22 |
| B07605200 | LZI Cotinine II Enzyme Immunoassay | LIN-ZHI INTERNATIONAL, INC. | 2022-04-22 |
| 00608337000030 | Kit, MP Cotinine Serum 100 plate | Orasure Technologies, Inc. | 2021-01-22 |
| 00859410006108 | Salimetrics | SALIMETRICS, LLC | 2018-09-14 |
| 00859410006092 | Salimetrics | SALIMETRICS, LLC | 2018-09-14 |
| 00884883001077 | DRI Cotinine Low Control | Microgenics Corporation | 2017-10-18 |
| 00884883001084 | DRI Cotinine High Control | Microgenics Corporation | 2017-10-18 |
| 00895160002366 | Nano-CheckTM Nicotine 500 | NANO-DITECH CORPORATION | 2016-10-04 |
| 00884883002876 | DRI Cotinine Assay | Microgenics Corporation | 2016-09-24 |
| 10743816000242 | Status™ Nicotine card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10743816000235 | AccuSign® Nicotine card | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 00884883001053 | DRI Cotinine Assay | Microgenics Corporation | 2016-09-22 |
| 00884883001060 | DRI Cotinine Calibrator Kit | Microgenics Corporation | 2016-09-22 |
| 00608337000672 | Cotinine OraSure 100 Plate Kit | Orasure Technologies, Inc. | 2016-09-16 |
| 00608337000665 | Cotinine OraSure 5 Plate Kit | Orasure Technologies, Inc. | 2016-09-16 |
| 00608337000405 | Cotinine Serum 2 Plate Kit | Orasure Technologies, Inc. | 2016-09-16 |
| 00608337000399 | Cotinine Serum 5 Plate Kit | Orasure Technologies, Inc. | 2016-09-16 |
| 00884883012905 | DRI Cotinine Assay | Microgenics Corporation | 2016-09-12 |
| 00895160002359 | Nano-CheckTM Nicotine | NANO-DITECH CORPORATION | 2016-09-12 |
| 00608337000085 | Auto-Lyte | Orasure Technologies, Inc. | 2016-04-29 |
| 00608337000474 | Auto-Lyte | Orasure Technologies, Inc. | 2016-04-29 |