The following data is part of a premarket notification filed by Amedica Biotech, Inc. with the FDA for Amedica Drug Screen Test Cup.
| Device ID | K082898 |
| 510k Number | K082898 |
| Device Name: | AMEDICA DRUG SCREEN TEST CUP |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2008-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817405020317 | K082898 | 000 |
| 00859144006009 | K082898 | 000 |
| 00858984006149 | K082898 | 000 |
| 00858984006132 | K082898 | 000 |
| 00858984006125 | K082898 | 000 |
| 00858984006118 | K082898 | 000 |
| 00858984006101 | K082898 | 000 |
| 00858984006095 | K082898 | 000 |
| 00858984006088 | K082898 | 000 |
| 00858984006071 | K082898 | 000 |
| 10763924935632 | K082898 | 000 |
| 10763924093639 | K082898 | 000 |
| 00859144006016 | K082898 | 000 |
| 00859144006023 | K082898 | 000 |
| 00817405020300 | K082898 | 000 |
| 00817405020294 | K082898 | 000 |
| 00816565020625 | K082898 | 000 |
| 00816565020618 | K082898 | 000 |
| 00816565020601 | K082898 | 000 |
| 00816555021502 | K082898 | 000 |
| 00816555021496 | K082898 | 000 |
| 00816555021489 | K082898 | 000 |
| 00859144006054 | K082898 | 000 |
| 00859144006047 | K082898 | 000 |
| 00859144006030 | K082898 | 000 |
| 10763924084651 | K082898 | 000 |