The following data is part of a premarket notification filed by Amedica Biotech, Inc. with the FDA for Amedica Drug Test Thc, Coc, Opi, Amp, Met, Pcp, Bar, Bzo, Mdma, Oxy, Tca.
| Device ID | K100108 |
| 510k Number | K100108 |
| Device Name: | AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA |
| Classification | Test, Opiates, Over The Counter |
| 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 | NGL |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJR |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LFG |
| Subsequent Product Code | NFT |
| Subsequent Product Code | NFV |
| Subsequent Product Code | NFW |
| Subsequent Product Code | NFY |
| Subsequent Product Code | NGG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-14 |
| Decision Date | 2010-04-14 |