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FDA 510(k)

Medconn 8K Glycated Hemoglobin Test System

K-Number: K252749 · 2026-01-06

ApplicantShanghai Medconn Medical Technology Co., Ltd.
Decision Date2026-01-06
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Medconn 8K Glycated Hemoglobin Test System is a medical device manufactured by Shanghai Medconn Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-01-06 under approval number K252749. 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 8K Glycated Hemoglobin Test System?

Medconn 8K Glycated Hemoglobin Test System is a medical device that received FDA 510(k) clearance on 2026-01-06. It is manufactured by Shanghai Medconn Medical Technology Co., Ltd.. The 510(k) number is K252749.

When was Medconn 8K Glycated Hemoglobin Test System approved by the FDA?

Medconn 8K Glycated Hemoglobin Test System received FDA 510(k) clearance on 2026-01-06, under approval number K252749.

What company makes Medconn 8K Glycated Hemoglobin Test System?

Medconn 8K Glycated Hemoglobin Test System is manufactured by Shanghai Medconn Medical Technology Co., Ltd..

What is the FDA product code for Medconn 8K Glycated Hemoglobin Test System?

The FDA product code for Medconn 8K Glycated Hemoglobin Test System is PDJ.

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

K242911Medconn Glycated Hemoglobin Test system

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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