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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 the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Medconn Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-20 under 510(k) 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. The listed applicant is Shanghai Medconn Medical Technology Co., Ltd.. The 510(k) number is K242911.

When did Medconn Glycated Hemoglobin Test system receive FDA 510(k) clearance?

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

Who is the listed applicant for Medconn Glycated Hemoglobin Test system?

The FDA 510(k) record lists Shanghai Medconn Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Shanghai Medconn Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252749Medconn 8K Glycated Hemoglobin Test System

Related Devices (Code: PDJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc.K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.K200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc.K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.K193053Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics Operations (Rdo)

Official Source

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

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