The following data is part of a premarket notification filed by Ameditech, Inc. with the FDA for Ameditech Drugsmartcup.
| Device ID | K053175 |
| 510k Number | K053175 |
| Device Name: | AMEDITECH DRUGSMARTCUP |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2005-12-08 |