H100Plus Hemoglobin Testing System— 510(k) K260468

Name: FDA 510(k) clearance K260468
Creator: U.S. Food and Drug Administration
Published: 2026-10-02

Substantially Equivalent

Shenzhen Lifotronic Technology Co., Ltd.

FDA 510(k) clearance K260468 for H100Plus Hemoglobin Testing System, Substantially Equivalent on 2026-10-02. Applicant: Shenzhen Lifotronic Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Lifotronic Technology Co., Ltd.
Product code: Code PDJ
Device class: Class 2
Regulation: 21 CFR 862.1373
Advisory panel: Clinical Chemistry
Date received: 2026-02-12
Decision date: 2026-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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