The following data is part of a premarket notification filed by Amedica Biotech, Inc. with the FDA for Amedicheck Drug Screen Thc, Coc, Opi, Amp, Met, Pcp, Mdma,bar, Bz.
| Device ID | K080872 |
| 510k Number | K080872 |
| Device Name: | AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ |
| 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 | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | JXO |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-08-19 |