The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, Controls.
| Device ID | K131653 |
| 510k Number | K131653 |
| Device Name: | LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-05 |
| Decision Date | 2014-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B076S0047B0 | K131653 | 000 |
| B076S0046B0 | K131653 | 000 |
| B076S0045B0 | K131653 | 000 |
| B076S0044B0 | K131653 | 000 |
| B076S0043B0 | K131653 | 000 |
| B076S0042B0 | K131653 | 000 |
| B076S0041B0 | K131653 | 000 |
| B076S0040B0 | K131653 | 000 |