The following data is part of a premarket notification filed by Shenzhen Bioeasy Biotechnology Co.,ltd. with the FDA for Bioeasy Marijuana Test Dip Card, Bioeasy Marijuana Test Strip.
Device ID | K192301 |
510k Number | K192301 |
Device Name: | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip |
Classification | Test, Cannabinoid, 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 International, Inc. 504E Diamond Ave., Suite I Gaithersburg, MD 20877 |
Product Code | NFW |
CFR Regulation Number | 862.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-23 |
Decision Date | 2019-09-20 |
Summary: | summary |