The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Buprenorphine Enzyme Immunoassay, Calibrators And Controls For Beckman Coulter Synchron Systems.
| Device ID | K081008 |
| 510k Number | K081008 |
| Device Name: | BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Contact | Marie Lin |
| Correspondent | Marie Lin Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| 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 | 2008-04-10 |
| Decision Date | 2008-12-22 |
| Summary: | summary |