LZI Tramadol Enzyme Immunoassay

Enzyme Immunoassay, Opiates

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Tramadol Enzyme Immunoassay.

Pre-market Notification Details

Device IDK201223
510k NumberK201223
Device Name:LZI Tramadol Enzyme Immunoassay
ClassificationEnzyme Immunoassay, Opiates
Applicant Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara,  CA  95051
ContactBernice Lin
CorrespondentBernice Lin
Lin-Zhi International, Inc. 2945 Oakmead Village Court Santa Clara,  CA  95051
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-06
Decision Date2020-06-04

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