The following data is part of a premarket notification filed by Amedica Biotech, Inc. with the FDA for Amedica Drug Screen Mdma-bar-bzo-mtd-tca Test.
| Device ID | K031497 |
| 510k Number | K031497 |
| Device Name: | AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST |
| Classification | Thin Layer Chromatography, Methamphetamine |
| 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 | DJC |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | MLK |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-13 |
| Decision Date | 2003-10-17 |