The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ml), (15ml); Controls; (5ml), (15ml).
| Device ID | K141055 |
| 510k Number | K141055 |
| Device Name: | LZI HYDROCODONE; ENZYME IMMUNOASSAY, CALIBRATORS; (5ML), (15ML); CONTROLS; (5ML), (15ML) |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
| Contact | Bernice Lin |
| Correspondent | Bernice Lin Lin-Zhi International, Inc. 670 ALMANOR AVE Sunnyvale, CA 94085 |
| Product Code | DJG |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727016843 | K141055 | 000 |
| 00811727016706 | K141055 | 000 |
| 00811727016713 | K141055 | 000 |
| 00811727016720 | K141055 | 000 |
| 00811727016737 | K141055 | 000 |
| 00811727016744 | K141055 | 000 |
| 00811727016751 | K141055 | 000 |
| 00811727016768 | K141055 | 000 |
| 00811727016775 | K141055 | 000 |
| 00811727016782 | K141055 | 000 |
| 00811727016799 | K141055 | 000 |
| 00811727016805 | K141055 | 000 |
| 00811727016812 | K141055 | 000 |
| 00811727016829 | K141055 | 000 |
| 00811727016836 | K141055 | 000 |
| 00811727016690 | K141055 | 000 |