K192299 is an FDA 510(k) clearance for the LZI Cotinine II Enzyme Immunoassay. This device is classified as a Enzyme Immunoassay, Nicotine And Nicotine Metabolites (Class I - General Controls, product code MKU).
Submitted by Lin-Zhi International, Inc. (Santa Clara, US). The FDA issued a Cleared decision on November 21, 2019, 90 days after receiving the submission on August 23, 2019.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3220.
| 510(k) Number | K192299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2019 |
| Decision Date | November 21, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MKU — Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.3220 |