The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Oral Fluid 6-acetylmorphine Enzyme Immunoassay, Lzi Oral Fluid 6-acetylmorphine Calibrators (5 Ml), Lzi Oral Fluid 6.
| Device ID | K141205 |
| 510k Number | K141205 |
| Device Name: | LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 |
| 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 | 2014-05-09 |
| Decision Date | 2015-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B076S02980 | K141205 | 000 |
| B076S02970 | K141205 | 000 |
| B076S02950 | K141205 | 000 |
| B076S02940 | K141205 | 000 |
| B076S02930 | K141205 | 000 |
| B076S02920 | K141205 | 000 |
| B076S02910 | K141205 | 000 |
| B076S02900 | K141205 | 000 |