The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Fentanyl Enzyme Immunoassay.
| Device ID | K181159 |
| 510k Number | K181159 |
| Device Name: | LZI Fentanyl 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 | 2018-05-01 |
| Decision Date | 2018-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07603110 | K181159 | 000 |
| B07603100 | K181159 | 000 |
| 00811727016416 | K181159 | 000 |
| 00811727016409 | K181159 | 000 |
| 00850624008353 | K181159 | 000 |