The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Oxycodone Iii Enzyme Immunoassay.
| Device ID | K202007 |
| 510k Number | K202007 |
| Device Name: | LZI Oxycodone III Enzyme Immunoassay |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara, CA 95051 |
| Contact | Bernice Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara, CA 95051 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-21 |
| Decision Date | 2020-09-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07606110 | K202007 | 000 |
| B07606100 | K202007 | 000 |