CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids

Enzyme Immunoassay, Opiates

GUANGZHOU WONDFO BIOTECH CO., LTD.

The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Cr3 Keyless Split Sample Cup Oxycodone - Cannabinoids.

Pre-market Notification Details

Device IDK150179
510k NumberK150179
Device Name:CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids
ClassificationEnzyme Immunoassay, Opiates
Applicant GUANGZHOU WONDFO BIOTECH CO., LTD. WONDFO SCIENTECH PARK, SOUTH CHINA UNIV. OF TECHNOLOGY Guangzhou,  CN 510641
ContactBen Chen
CorrespondentJoe Shia
LSI INTERNATIONAL INC. 504 East Diamond Ave. Suite F Giathersburg,  MD  20878
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-27
Decision Date2015-02-25
Summary:summary

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