QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE

Enzyme Immunoassay, Cannabinoids

LUMIQUICK DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Lumiquick Diagnostics, Inc. with the FDA for Quickprofile Single Drug Of Abuse Device And Quick Profile Multi-drugs Of Abuse Screen Device.

Pre-market Notification Details

Device IDK130213
510k NumberK130213
Device Name:QUICKPROFILE SINGLE DRUG OF ABUSE DEVICE AND QUICK PROFILE MULTI-DRUGS OF ABUSE SCREEN DEVICE
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant LUMIQUICK DIAGNOSTICS, INC. 27001 LA PAZ RD, STE 266B Mission Viejo,  CA  92691
ContactFeng-yu Lee
CorrespondentFeng-yu Lee
LUMIQUICK DIAGNOSTICS, INC. 27001 LA PAZ RD, STE 266B Mission Viejo,  CA  92691
Product CodeLDJ  
Subsequent Product CodeDIO
Subsequent Product CodeDIS
Subsequent Product CodeDJC
Subsequent Product CodeDJG
Subsequent Product CodeDJR
Subsequent Product CodeDKZ
Subsequent Product CodeJXM
Subsequent Product CodeLCM
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-29
Decision Date2013-10-18
Summary:summary

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