Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card— 510(k) K232228

Name: FDA 510(k) clearance K232228
Creator: U.S. Food and Drug Administration
Published: 2024-02-23

Substantially Equivalent

Shanghai Accurature Diagnostics Co., Ltd.

FDA 510(k) clearance K232228 for Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card, Substantially Equivalent on 2024-02-23. Applicant: Shanghai Accurature Diagnostics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Accurature Diagnostics Co., Ltd.
Product code: Product code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2023-07-27
Decision date: 2024-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.