The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Oral Fluid Cannabinoids Enzyme Immunoassay, Lzi Oral Fluid Cannabinoids Calibrators And Lzi Oral Fluid Cannabinoids Controls.
| Device ID | K141320 |
| 510k Number | K141320 |
| Device Name: | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators And LZI Oral Fluid Cannabinoids Controls |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | Lin-Zhi International, Inc. 670 ALMANOR AVE. Sunnyvale, CA 94085 |
| Contact | Berniece Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALMANOR AVE. Sunnyvale, CA 94085 |
| Product Code | LDJ |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2015-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B076S0078C0 | K141320 | 000 |
| B076S0077C0 | K141320 | 000 |
| B076S0076C0 | K141320 | 000 |
| B076S0075C0 | K141320 | 000 |
| B076S0074C0 | K141320 | 000 |
| B076S0073C0 | K141320 | 000 |
| B076S0072C0 | K141320 | 000 |
| B076S0071C0 | K141320 | 000 |
| B076S0070C0 | K141320 | 000 |