The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Opiate 2000 Homogeneous Enzyme Immunoassay, Lzi Opiate 2000 Calibrators, Lzi Opiate 2000 Controls.
| Device ID | K120761 |
| 510k Number | K120761 |
| Device Name: | LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 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 | 2012-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B07603380 | K120761 | 000 |
| 00811727016959 | K120761 | 000 |
| 00811727016966 | K120761 | 000 |
| 00811727016973 | K120761 | 000 |
| 00811727016980 | K120761 | 000 |
| 00811727016997 | K120761 | 000 |
| 00811727017000 | K120761 | 000 |
| 00811727017017 | K120761 | 000 |
| B07603300 | K120761 | 000 |
| B07603310 | K120761 | 000 |
| B07603320 | K120761 | 000 |
| B07603330 | K120761 | 000 |
| B07603340 | K120761 | 000 |
| B07603350 | K120761 | 000 |
| B07603370 | K120761 | 000 |
| 00811727016942 | K120761 | 000 |