Cleared Traditional

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard

K231137 · Xenta Biomedical Science Co., Ltd. · Toxicology
May 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K231137 is an FDA 510(k) clearance for the Xenta Drug Screen Cup, Xenta Drug Screen Dipcard, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Xenta Biomedical Science Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 19, 2023, 28 days after receiving the submission on April 21, 2023. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K231137 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2023
Decision Date May 19, 2023
Days to Decision 28 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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