K203647 is an FDA 510(k) clearance for the SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay. This device is classified as a Gas Chromatography, Methamphetamine (Class II - Special Controls, product code LAF).
Submitted by Immunalysis Corporation (Pomona, US). The FDA issued a Cleared decision on December 22, 2021, 373 days after receiving the submission on December 14, 2020.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K203647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 2020 |
| Decision Date | December 22, 2021 |
| Days to Decision | 373 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 |