WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST

Enzyme Immunoassay, Cannabinoids

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 Cannabinoids Urine Test Wondfo Propoxyphene Urine Test.

Pre-market Notification Details

Device IDK121557
510k NumberK121557
Device Name:WONDFO CANNABINOIDS URINE TEST WONDFO PROPOXYPHENE URINE TEST
ClassificationEnzyme Immunoassay, Cannabinoids
Applicant Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. Suite F Gaithersburg,  MD  20877
ContactJoe Shia
CorrespondentJoe Shia
Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. Suite F Gaithersburg,  MD  20877
Product CodeLDJ  
CFR Regulation Number862.3870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-05-25
Decision Date2012-07-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00855944007642 K121557 000
10810038632015 K121557 000
30810038630152 K121557 000
00850253007246 K121557 000
00850253007253 K121557 000
10850253007298 K121557 000
10850253007915 K121557 000
10855944007465 K121557 000
00855944007475 K121557 000
00855944007482 K121557 000
10810038631636 K121557 000

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