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FDA 510(k)

H100Plus Hemoglobin Testing System

K-Number: K260468 · 2026-10-02

ApplicantShenzhen Lifotronic Technology Co., Ltd.
Decision Date2026-10-02
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

H100Plus Hemoglobin Testing System is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lifotronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-10-02 under 510(k) number K260468. 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 H100Plus Hemoglobin Testing System?

H100Plus Hemoglobin Testing System is a medical device that received FDA 510(k) clearance on 2026-10-02. The listed applicant is Shenzhen Lifotronic Technology Co., Ltd.. The 510(k) number is K260468.

When did H100Plus Hemoglobin Testing System receive FDA 510(k) clearance?

H100Plus Hemoglobin Testing System received FDA 510(k) clearance on 2026-10-02, under 510(k) number K260468.

Who is the listed applicant for H100Plus Hemoglobin Testing System?

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

What is the FDA product code for H100Plus Hemoglobin Testing System?

The FDA product code for H100Plus Hemoglobin Testing System is PDJ.

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Other records listing Shenzhen Lifotronic Technology Co., Ltd. as applicant

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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.K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.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.

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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