K010646 is an FDA 510(k) clearance for the AT HOME DRUG TEST, MODEL 9083 T. This device is classified as a Kit, Test, Multiple, Drugs Of Abuse, Over The Counter.
Submitted by Phamatech (San Diego, US). The FDA issued a Cleared decision on March 30, 2001, 25 days after receiving the submission on March 5, 2001.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K010646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2001 |
| Decision Date | March 30, 2001 |
| Days to Decision | 25 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MVO — Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Device Class | — |