K003858 is an FDA 510(k) clearance for the MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175. 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 February 12, 2001, 61 days after receiving the submission on December 13, 2000.
This device falls under the Toxicology FDA review panel.
| 510(k) Number | K003858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2000 |
| Decision Date | February 12, 2001 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MVO — Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Device Class | — |