The following data is part of a premarket notification filed by Amedica Biotech, Inc. with the FDA for Amedica Drug Screen Thc/coc, Op1300, Ppx, Oxy, Bar/bzo Test.
| Device ID | K040464 |
| 510k Number | K040464 |
| Device Name: | AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | AMEDICA BIOTECH, INC. 28301 INDUSTRIAL BLVD SUITE K Hayward, CA 94545 |
| Contact | Jeff Chen |
| Correspondent | Jeff Chen AMEDICA BIOTECH, INC. 28301 INDUSTRIAL BLVD SUITE K Hayward, CA 94545 |
| Product Code | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-23 |
| Decision Date | 2004-05-17 |