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FDA 510(k)

A1C EZ Glycohemoglobin Analysis System

K-Number: K161533 · 2017-06-16

ApplicantBiohermes Co., Ltd.
Decision Date2017-06-16
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

A1C EZ Glycohemoglobin Analysis System is a medical device manufactured by Biohermes Co., Ltd.. It received FDA 510(k) clearance on 2017-06-16 under approval number K161533. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A1C EZ Glycohemoglobin Analysis System?

A1C EZ Glycohemoglobin Analysis System is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Biohermes Co., Ltd.. The 510(k) number is K161533.

When was A1C EZ Glycohemoglobin Analysis System approved by the FDA?

A1C EZ Glycohemoglobin Analysis System received FDA 510(k) clearance on 2017-06-16, under approval number K161533.

What company makes A1C EZ Glycohemoglobin Analysis System?

A1C EZ Glycohemoglobin Analysis System is manufactured by Biohermes Co., Ltd..

What is the FDA product code for A1C EZ Glycohemoglobin Analysis System?

The FDA product code for A1C EZ Glycohemoglobin Analysis System is LCP.

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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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