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 | K182123 |
| 510k Number | K182123 |
| Device Name: | ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Advin Biotech, Inc. 10340 Camino Santa Fe, Suite G San Diego, CA 92121 |
| Contact | Lorraine Cogan |
| Correspondent | Daniel Hsu Advin Biotech, Inc. 10340 Camino Santa Fe, Suite G San Diego, CA 92121 |
| Product Code | DJG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DKZ |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-06 |
| Decision Date | 2019-03-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858984006323 | K182123 | 000 |
| 00858984006316 | K182123 | 000 |
| 00858984006309 | K182123 | 000 |
| 00858984006293 | K182123 | 000 |
| B115PATCARD016AM0 | K182123 | 000 |
| 00858886006780 | K182123 | 000 |
| 00858886006797 | K182123 | 000 |