CR3 Keyless Split Sample Cup Morphine - Methamphetamine

Thin Layer Chromatography, Morphine

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 Morphine - Methamphetamine.

Pre-market Notification Details

Device IDK150602
510k NumberK150602
Device Name:CR3 Keyless Split Sample Cup Morphine - Methamphetamine
ClassificationThin Layer Chromatography, Morphine
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 Gaithersburg,  MD  20878
Product CodeDNK  
CFR Regulation Number862.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-10
Decision Date2015-04-07
Summary:summary

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