Xenta Drug Screen Cup, Xenta Drug Screen Dipcard— 510(k) K231137

Name: FDA 510(k) clearance K231137
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Substantially Equivalent

Xenta Biomedical Science Co., Ltd.

FDA 510(k) clearance K231137 for Xenta Drug Screen Cup, Xenta Drug Screen Dipcard, Substantially Equivalent on 2023-05-19. Applicant: Xenta Biomedical Science Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xenta Biomedical Science Co., Ltd.
Product code: Code DKZ
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2023-04-21
Decision date: 2023-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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