LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators And LZI Oral Fluid Cannabinoids Controls

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 Oral Fluid Cannabinoids Enzyme Immunoassay, Lzi Oral Fluid Cannabinoids Calibrators And Lzi Oral Fluid Cannabinoids Controls.

Pre-market Notification Details

Device IDK141320
510k NumberK141320
Device Name:LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators And LZI Oral Fluid Cannabinoids Controls
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant Lin-Zhi International, Inc. 670 ALMANOR AVE. Sunnyvale,  CA  94085
ContactBerniece Lin
CorrespondentBernice Lin
Lin-Zhi International, Inc. 670 ALMANOR AVE. 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 Received2014-05-20
Decision Date2015-05-28
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B076S0078C0 K141320 000
B076S0077C0 K141320 000
B076S0076C0 K141320 000
B076S0075C0 K141320 000
B076S0074C0 K141320 000
B076S0073C0 K141320 000
B076S0072C0 K141320 000
B076S0071C0 K141320 000
B076S0070C0 K141320 000

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