Device Classification Name |
Gas Chromatography, Methamphetamine
|
510(k) Number |
K201442 |
Device Name |
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers |
Applicant |
Diatron Group |
12601 N.W. 115th Avenue, Suite A113 |
Medley,
FL
33178
|
|
Applicant Contact |
Frank Matuszak |
Correspondent |
Ammirati Regulatory Consulting |
575 Shirlynn Court |
Los Altos,
CA
94022
|
|
Correspondent Contact |
Erika Ammirati |
Regulation Number | 862.3610
|
Classification Product Code |
|
Date Received | 06/01/2020 |
Decision Date | 07/31/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|