The following data is part of a premarket notification filed by Guangzhou Wondfo Biotech Co., Ltd. with the FDA for Cannabinoids Urine Test.
Device ID | K110182 |
510k Number | K110182 |
Device Name: | CANNABINOIDS URINE TEST |
Classification | Enzyme Immunoassay, Cannabinoids |
Applicant | Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20878 |
Contact | Joe Shia |
Correspondent | Joe Shia Guangzhou Wondfo Biotech Co., Ltd. 504 EAST DIAMOND AVE. SUITE F Gaithersburg, MD 20878 |
Product Code | LDJ |
CFR Regulation Number | 862.3870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-01-21 |
Decision Date | 2011-05-20 |
Summary: | summary |