Cleared Traditional

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

K222955 · Xenta Biomedical Science Co., Ltd. · Toxicology

Feb 2023

Decision

132d

Days

Class 2

Risk

About This 510(k) Submission

K222955 is an FDA 510(k) clearance for the Xenta Drug Screen Cup, Xenta Drug Screen Dipcard, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Xenta Biomedical Science Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on February 6, 2023, 132 days after receiving the submission on September 27, 2022. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number	K222955 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 27, 2022
Decision Date	February 06, 2023
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	Summary PDF