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 |