The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators And Controls.
| Device ID | K050988 |
| 510k Number | K050988 |
| Device Name: | OPIATE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS |
| Classification | Coating, Liquid, Glc |
| 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 | DLG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.2250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-19 |
| Decision Date | 2006-04-06 |
| Summary: | summary |