The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Cannabinoids (cthc) Homogeneous Enzyme Immunoassay, Calibrators, Control.
| Device ID | K110239 |
| 510k Number | K110239 |
| Device Name: | LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale, CA 94085 |
| Contact | Bernice Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALmanor Avenue 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 | 2011-01-26 |
| Decision Date | 2011-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0760079C0 | K110239 | 000 |
| 00811727017376 | K110239 | 000 |
| 00811727017369 | K110239 | 000 |
| 00811727017352 | K110239 | 000 |
| 00811727017345 | K110239 | 000 |
| 00811727017338 | K110239 | 000 |
| 00811727017321 | K110239 | 000 |
| 00811727017314 | K110239 | 000 |
| 00811727017307 | K110239 | 000 |
| 00811727017291 | K110239 | 000 |
| 00811727017284 | K110239 | 000 |
| 00811727017277 | K110239 | 000 |
| 00811727017260 | K110239 | 000 |
| 00811727017253 | K110239 | 000 |
| 00811727017383 | K110239 | 000 |
| B0760002C0 | K110239 | 000 |
| B0760078C0 | K110239 | 000 |
| B0760077C0 | K110239 | 000 |
| B0760076C0 | K110239 | 000 |
| B0760075C0 | K110239 | 000 |
| B0760074C0 | K110239 | 000 |
| B0760073C0 | K110239 | 000 |
| B0760072C0 | K110239 | 000 |
| B0760071C0 | K110239 | 000 |
| B0760070C0 | K110239 | 000 |
| B0760009C0 | K110239 | 000 |
| B0760008C0 | K110239 | 000 |
| B0760007C0 | K110239 | 000 |
| B0760006C0 | K110239 | 000 |
| 00811727017246 | K110239 | 000 |