The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Fentanyl Ii Enzyme Immunoassay.
| Device ID | K201938 |
| 510k Number | K201938 |
| Device Name: | LZI Fentanyl II 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 | 2020-07-13 |
| Decision Date | 2020-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850624008254 | K201938 | 000 |
| 00850624008261 | K201938 | 000 |
| B07605710 | K201938 | 000 |
| B07605700 | K201938 | 000 |