K062242 is an FDA 510(k) clearance for the METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY. This device is classified as a Gas Chromatography, Methamphetamine (Class II - Special Controls, product code LAF).
Submitted by Lin-Zhi International, Inc. (Synnyvale, US). The FDA issued a Cleared decision on September 29, 2006, 58 days after receiving the submission on August 2, 2006.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K062242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 2006 |
| Decision Date | September 29, 2006 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LAF — Gas Chromatography, Methamphetamine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3610 |