The following data is part of a premarket notification filed by Advantage Diagnostics Corp. with the FDA for Peace Of Mind Home Drug Test.
| Device ID | K013778 |
| 510k Number | K013778 |
| Device Name: | PEACE OF MIND HOME DRUG TEST |
| Classification | Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
| Applicant | ADVANTAGE DIAGNOSTICS CORP. 1201 DOUGLAS AVE. Redwood City, CA 94063 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone ADVANTAGE DIAGNOSTICS CORP. 1201 DOUGLAS AVE. Redwood City, CA 94063 |
| Product Code | MVO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-02-07 |
| Summary: | summary |