The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Oral Fluid Methamphetamine Enzyme Immunoassay, Calibrators, Controls.
| Device ID | K131652 |
| 510k Number | K131652 |
| Device Name: | LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS |
| Classification | Gas Chromatography, Methamphetamine |
| 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 | 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 | 2013-06-05 |
| Decision Date | 2014-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B076S0057B0 | K131652 | 000 |
| B076S00010 | K131652 | 000 |
| B076S0050B0 | K131652 | 000 |
| B076S0051B0 | K131652 | 000 |
| B076S0052B0 | K131652 | 000 |
| B076S0053B0 | K131652 | 000 |
| B076S0054B0 | K131652 | 000 |
| B076S0055B0 | K131652 | 000 |
| B076S0056B0 | K131652 | 000 |
| B076S0000B1 | K131652 | 000 |