The following data is part of a premarket notification filed by Diatron Group with the FDA for Lin-zhi International, Inc. (lzi) Methamphetamine Enzyme Immunoassay For Pictus Analyzers.
| Device ID | K201442 |
| 510k Number | K201442 |
| Device Name: | Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay For Pictus Analyzers |
| Classification | Gas Chromatography, Methamphetamine |
| Applicant | Diatron Group 12601 N.W. 115th Avenue, Suite A113 Medley, FL 33178 |
| Contact | Frank Matuszak |
| Correspondent | Erika Ammirati Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | LAF |
| CFR Regulation Number | 862.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2020-07-31 |