The following data is part of a premarket notification filed by Advantage Diagnostics Corp. with the FDA for Advantage Thc Test.
| Device ID | K001567 |
| 510k Number | K001567 |
| Device Name: | ADVANTAGE THC TEST |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-19 |
| Decision Date | 2000-06-19 |