The following data is part of a premarket notification filed by Ameditech, Inc. with the FDA for Ameditech Immutest Multi-drug Screen Bup/ppx/coc150.
| Device ID | K063015 |
| 510k Number | K063015 |
| Device Name: | AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | AMEDITECH, INC. 10340 CAMINO SANTA FE SUITE F San Diego, CA 92121 |
| Contact | John Wu |
| Correspondent | John Wu AMEDITECH, INC. 10340 CAMINO SANTA FE SUITE F San Diego, CA 92121 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | JXN |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2006-12-20 |