K140546 is an FDA 510(k) clearance for the HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Healgen Scientific, LLC (Gaithersburg, US). The FDA issued a Cleared decision on June 6, 2014, 94 days after receiving the submission on March 4, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K140546 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2014 |
| Decision Date | June 06, 2014 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |