The following data is part of a premarket notification filed by Advantage Diagnostics Corp. with the FDA for Advantage Thc/cocaine Test.
| Device ID | K003708 |
| 510k Number | K003708 |
| Device Name: | ADVANTAGE THC/COCAINE TEST |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-01 |
| Decision Date | 2001-01-22 |