Wondfo Propoxyphene Urine Test

Enzyme Immunoassay, Propoxyphene

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 Wondfo Propoxyphene Urine Test.

Pre-market Notification Details

Device IDK152495
510k NumberK152495
Device Name:Wondfo Propoxyphene Urine Test
ClassificationEnzyme Immunoassay, Propoxyphene
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 I Gaithersburg,  MD  20877
Product CodeJXN  
CFR Regulation Number862.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-01
Decision Date2015-11-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816036025623 K152495 000

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