BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx— 510(k) K230238

Name: FDA 510(k) clearance K230238
Creator: U.S. Food and Drug Administration
Published: 2023-03-31

Substantially Equivalent

Shenzhen Bioeasy Biotechnology Co., Ltd.

FDA 510(k) clearance K230238 for BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx, Substantially Equivalent on 2023-03-31. Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Bioeasy Biotechnology Co., Ltd.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2023-01-30
Decision date: 2023-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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