LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

Enzyme Immunoassay, Amphetamine

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 Amphetamine Enzyme Immunoassay, Calibrators, Controls.

Pre-market Notification Details

Device IDK131653
510k NumberK131653
Device Name:LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS
ClassificationEnzyme Immunoassay, Amphetamine
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 CodeDKZ  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-05
Decision Date2014-02-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B076S0047B0 K131653 000
B076S0046B0 K131653 000
B076S0045B0 K131653 000
B076S0044B0 K131653 000
B076S0043B0 K131653 000
B076S0042B0 K131653 000
B076S0041B0 K131653 000
B076S0040B0 K131653 000

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