The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Methadone Metabolite Enzyme Immunoassay, Lzi Methadone Metabolite (100 And 300) Calibrators.
| Device ID | K170416 |
| 510k Number | K170416 |
| Device Name: | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 And 300) Calibrators |
| Classification | Enzyme Immunoassay, Methadone |
| 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 | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-10 |
| Decision Date | 2017-06-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0760205B0 | K170416 | 000 |
| B0760191B0 | K170416 | 000 |
| B0760192B0 | K170416 | 000 |
| B0760193B0 | K170416 | 000 |
| B0760194B0 | K170416 | 000 |
| B0760195B0 | K170416 | 000 |
| B0760202B0 | K170416 | 000 |
| B0760203B0 | K170416 | 000 |
| B0760204B0 | K170416 | 000 |
| B0760190B0 | K170416 | 000 |