Medconn Glycated Hemoglobin Test system— 510(k) K242911

Name: FDA 510(k) clearance K242911
Creator: U.S. Food and Drug Administration
Published: 2025-06-20

Substantially Equivalent

Shanghai Medconn Medical Technology Co., Ltd.

FDA 510(k) clearance K242911 for Medconn Glycated Hemoglobin Test system, Substantially Equivalent on 2025-06-20. Applicant: Shanghai Medconn Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Medconn Medical Technology Co., Ltd.
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2024-09-24
Decision date: 2025-06-20
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.