K131652 is an FDA 510(k) clearance for the LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS. This device is classified as a Gas Chromatography, Methamphetamine (Class II - Special Controls, product code LAF).
Submitted by Lin-Zhi International, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 21, 2014, 289 days after receiving the submission on June 5, 2013.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K131652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2013 |
| Decision Date | March 21, 2014 |
| Days to Decision | 289 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LAF — Gas Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |