The following data is part of a premarket notification filed by Ameditech, Inc. with the FDA for Ameditech Immutest Multi-drug Screen Panel Ii.
| Device ID | K042975 |
| 510k Number | K042975 |
| Device Name: | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-28 |
| Decision Date | 2004-12-29 |