Wondfo T-Cup Multi-Drug Urine Test Cup

Test, Amphetamine, Over The Counter

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 T-cup Multi-drug Urine Test Cup.

Pre-market Notification Details

• Device ID: K182701
• 510k Number: K182701
• Device Name: Wondfo T-Cup Multi-Drug Urine Test Cup
• Classification: Test, Amphetamine, Over The Counter
• Applicant: Guangzhou Wondfo Biotech Co., Ltd. No.8 Lizhishan Road, Science City Guangzhou, CN 510641
• Contact: Bin Chen
• Correspondent: Joe Shia; LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
• Product Code: NFT
• Subsequent Product Code: LCK
• Subsequent Product Code: NFV
• Subsequent Product Code: NFW
• Subsequent Product Code: NFY
• Subsequent Product Code: NGG
• Subsequent Product Code: NGL
• Subsequent Product Code: PTG
• Subsequent Product Code: PTH
• Subsequent Product Code: QAW
• Subsequent Product Code: QBF
• CFR Regulation Number: 862.3100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-27
• Decision Date: 2018-12-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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