The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Methamphetamine Oral Fluid Homogeneous Enzyme Immunoassay; Calibrators And Controls.
| Device ID | K062242 |
| 510k Number | K062242 |
| Device Name: | METHAMPHETAMINE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY; CALIBRATORS AND CONTROLS |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | LAF |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2006-09-29 |
| Summary: | summary |