The following data is part of a premarket notification filed by Ameditech, Inc. with the FDA for Ameditech Immutest Drug Screen Opiates.
| Device ID | K012483 |
| 510k Number | K012483 |
| Device Name: | AMEDITECH IMMUTEST DRUG SCREEN OPIATES |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | AMEDITECH, INC. 10340 CAMINO SANTA FE SUITES F-G San Diego, CA 92121 |
| Contact | John Wu |
| Correspondent | John Wu AMEDITECH, INC. 10340 CAMINO SANTA FE SUITES F-G San Diego, CA 92121 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-02 |
| Decision Date | 2001-11-30 |