BIOEASY Multi-Drug Test Cup

Test, Amphetamine, Over The Counter

The following data is part of a premarket notification filed by Shenzhen Bioeasy Biotechnology Co.,ltd. with the FDA for Bioeasy Multi-drug Test Cup.

Device ID	K182530
510k Number	K182530
Device Name:	BIOEASY Multi-Drug Test Cup
Classification	Test, Amphetamine, Over The Counter
Applicant	Shenzhen Bioeasy Biotechnology Co.,Ltd. No.2-1, Liuxian 1st Road, Xin'an Sub-District Shenzhen, CN 518101
Contact	Wenhau Yan
Correspondent	Joe Shia LSI 504E Diamond Ave., Suite I Gaithersburg, MD 20877
Product Code	NFT
Subsequent Product Code	NFV
Subsequent Product Code	NFW
Subsequent Product Code	NFY
Subsequent Product Code	NGG
Subsequent Product Code	NGI
Subsequent Product Code	NGL
Subsequent Product Code	NGM
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	2018-09-14
Decision Date	2018-11-09
Summary:	summary