The following data is part of a premarket notification filed by Amedica Biotech, Inc. with the FDA for Amedica Drug Screen Opiates Test.
| Device ID | K023047 |
| 510k Number | K023047 |
| Device Name: | AMEDICA DRUG SCREEN OPIATES TEST |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-12 |
| Decision Date | 2002-11-06 |
| Summary: | summary |