WONDOFO MULTI-DRUG URINE TEST CUP / PANEL

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 Wondofo Multi-drug Urine Test Cup / Panel.

Pre-market Notification Details

Device IDK130665
510k NumberK130665
Device Name:WONDOFO MULTI-DRUG URINE TEST CUP / PANEL
ClassificationEnzyme Immunoassay, Opiates
Applicant Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg,  MD  20878
ContactJoe Shia
CorrespondentJoe Shia
Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg,  MD  20878
Product CodeDJG  
Subsequent Product CodeDIO
Subsequent Product CodeDIS
Subsequent Product CodeDKZ
Subsequent Product CodeJXM
Subsequent Product CodeLAF
Subsequent Product CodeLCM
Subsequent Product CodeLDJ
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-12
Decision Date2013-04-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816862025040 K130665 000
10816862020011 K130665 000
10816862020028 K130665 000
10816862020035 K130665 000
10816862020042 K130665 000
00816862025002 K130665 000
00816862025019 K130665 000
00816862025026 K130665 000
00816862025033 K130665 000
10816862020004 K130665 000

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