The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & Controls.
| Device ID | K050945 |
| 510k Number | K050945 |
| Device Name: | ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Contact | Cheng-i Lin |
| Correspondent | Cheng-i Lin Lin-Zhi International, Inc. 687 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2917 |
| Product Code | DIO |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-14 |
| Decision Date | 2006-03-29 |
| Summary: | summary |