Submission Details
| 510(k) Number | K013778 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 2001 |
| Decision Date | February 07, 2002 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
K013778 is an FDA 510(k) clearance for the PEACE OF MIND HOME DRUG TEST, a Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, submitted by Advantage Diagnostics Corp. (Redwood City, US). The FDA issued a Cleared decision on February 7, 2002, 86 days after receiving the submission on November 13, 2001. This device falls under the Toxicology review panel.
| 510(k) Number | K013778 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 13, 2001 |
| Decision Date | February 07, 2002 |
| Days to Decision | 86 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 | — |