A1C EZ Glycohemoglobin Analysis System— 510(k) K161533

Name: FDA 510(k) clearance K161533
Creator: U.S. Food and Drug Administration
Published: 2017-06-16

Substantially Equivalent

Biohermes Co., Ltd.

FDA 510(k) clearance K161533 for A1C EZ Glycohemoglobin Analysis System, Substantially Equivalent on 2017-06-16. Applicant: Biohermes Co., Ltd.. Device class: 2.

Clearance details

Applicant: Biohermes Co., Ltd.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2016-06-02
Decision date: 2017-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wuxi, CN

Download summary PDF View on FDA.gov ↗

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