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FDA 510(k)

Medconn Glycated Hemoglobin Test system

K-Number: K242911 · 2025-06-20

ApplicantShanghai Medconn Medical Technology Co., Ltd.
Decision Date2025-06-20
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Medconn Glycated Hemoglobin Test system is a medical device manufactured by Shanghai Medconn Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under approval number K242911. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medconn Glycated Hemoglobin Test system?

Medconn Glycated Hemoglobin Test system is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Shanghai Medconn Medical Technology Co., Ltd.. The 510(k) number is K242911.

When was Medconn Glycated Hemoglobin Test system approved by the FDA?

Medconn Glycated Hemoglobin Test system received FDA 510(k) clearance on 2025-06-20, under approval number K242911.

What company makes Medconn Glycated Hemoglobin Test system?

Medconn Glycated Hemoglobin Test system is manufactured by Shanghai Medconn Medical Technology Co., Ltd..

What is the FDA product code for Medconn Glycated Hemoglobin Test system?

The FDA product code for Medconn Glycated Hemoglobin Test system is PDJ.

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Other Devices by Shanghai Medconn Medical Technology Co., Ltd.

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Related Devices (Code: PDJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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