The following data is part of a premarket notification filed by Amedica Biotech, Inc. with the FDA for Amedica Drug Screen Thc, Coc, Opi, Amp, Met, Pcp, Mdma, Bar, Bzo, M, Models C1210, C1220.
| Device ID | K063379 |
| 510k Number | K063379 |
| Device Name: | AMEDICA DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA, BAR, BZO, M, MODELS C1210, C1220 |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2006-12-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816565020595 | K063379 | 000 |
| 00816555020277 | K063379 | 000 |
| 00816555020253 | K063379 | 000 |
| 00816555020239 | K063379 | 000 |
| 00858984006170 | K063379 | 000 |
| 00858984006156 | K063379 | 000 |
| 00858984006064 | K063379 | 000 |
| 00858984006057 | K063379 | 000 |
| 00858984006040 | K063379 | 000 |
| 00858984006033 | K063379 | 000 |
| 00858984006026 | K063379 | 000 |
| 00858984006019 | K063379 | 000 |
| 00816555020284 | K063379 | 000 |
| 00816555020291 | K063379 | 000 |
| 00816555020307 | K063379 | 000 |
| 00816565020588 | K063379 | 000 |
| 00816565020571 | K063379 | 000 |
| 00816565020564 | K063379 | 000 |
| 00816565020557 | K063379 | 000 |
| 00816565020540 | K063379 | 000 |
| 00816565020533 | K063379 | 000 |
| 00816565020526 | K063379 | 000 |
| 00816565020519 | K063379 | 000 |
| 00816565020502 | K063379 | 000 |
| 00816555021472 | K063379 | 000 |
| 00816555020314 | K063379 | 000 |
| 00858984006002 | K063379 | 000 |