K033299 is an FDA 510(k) clearance for the ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP AND TEST DEVICE. This device is classified as a Gas Chromatography, Methamphetamine (Class II - Special Controls, product code LAF).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on December 12, 2003, 59 days after receiving the submission on October 14, 2003.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3610.
| 510(k) Number | K033299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 14, 2003 |
| Decision Date | December 12, 2003 |
| Days to Decision | 59 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 |