The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls.
| Device ID | K120763 |
| 510k Number | K120763 |
| Device Name: | LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
| Contact | Bernice Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
| Product Code | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-13 |
| Decision Date | 2012-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0760252B0 | K120763 | 000 |
| 00811727017536 | K120763 | 000 |
| 00811727017529 | K120763 | 000 |
| 00811727017512 | K120763 | 000 |
| 00811727017505 | K120763 | 000 |
| 00811727017499 | K120763 | 000 |
| 00811727017482 | K120763 | 000 |
| 00811727017475 | K120763 | 000 |
| 00811727017468 | K120763 | 000 |
| 00811727017451 | K120763 | 000 |
| 00811727017543 | K120763 | 000 |
| B0760240B0 | K120763 | 000 |
| B0760249B0 | K120763 | 000 |
| B0760248B0 | K120763 | 000 |
| B0760247B0 | K120763 | 000 |
| B0760246B0 | K120763 | 000 |
| B0760245B0 | K120763 | 000 |
| B0760244B0 | K120763 | 000 |
| B0760243B0 | K120763 | 000 |
| B0760242B0 | K120763 | 000 |
| B0760241B0 | K120763 | 000 |
| 00811727017444 | K120763 | 000 |