The following data is part of a premarket notification filed by Advin Biotech, Inc. with the FDA for Attest Drug Screen Cup, Attest Drug Screen Dip Card.
| Device ID | K201494 |
| 510k Number | K201494 |
| Device Name: | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Advin Biotech, Inc. 10237 Flanders Ct San Diego, CA 92121 |
| Contact | Daniel Hsu |
| Correspondent | Daniel Hsu Advin Biotech, Inc. 10237 Flanders Ct San Diego, CA 92121 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| Subsequent Product Code | LFG |
| Subsequent Product Code | NGG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-05 |
| Decision Date | 2020-09-17 |