LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL

Enzyme Immunoassay, Cannabinoids

Lin-Zhi International, Inc.

The following data is part of a premarket notification filed by Lin-zhi International, Inc. with the FDA for Lzi Cannabinoids (cthc) Homogeneous Enzyme Immunoassay, Calibrators, Control.

Pre-market Notification Details

Device IDK110239
510k NumberK110239
Device Name:LZI CANNABINOIDS (CTHC) HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS, CONTROL
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale,  CA  94085
ContactBernice Lin
CorrespondentBernice Lin
Lin-Zhi International, Inc. 670 ALmanor Avenue Sunnyvale,  CA  94085
Product CodeLDJ  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-26
Decision Date2011-06-23
Summary:summary

NIH GUDID Devices

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