K010921 is an FDA 510(k) clearance for the ADVANTAGE MARIJUANA (THC) HOME DRUG TEST. This device is classified as a Enzyme Immunoassay, Cannabinoids (Class II - Special Controls, product code LDJ).
Submitted by Advantage Diagnostics Corp. (Redwood City, US). The FDA issued a Cleared decision on June 25, 2001, 90 days after receiving the submission on March 27, 2001.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3870.
| 510(k) Number | K010921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2001 |
| Decision Date | June 25, 2001 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LDJ — Enzyme Immunoassay, Cannabinoids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3870 |