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FDA 510(k)

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8

K-Number: K200904 · 2021-08-05

ApplicantTosoh Bioscience, Inc.
Decision Date2021-08-05
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is a medical device manufactured by Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2021-08-05 under approval number K200904. 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 Tosoh Automated Glycohemoglobin Analyzer HLC-723G8?

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is a medical device that received FDA 510(k) clearance on 2021-08-05. It is manufactured by Tosoh Bioscience, Inc.. The 510(k) number is K200904.

When was Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 approved by the FDA?

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 received FDA 510(k) clearance on 2021-08-05, under approval number K200904.

What company makes Tosoh Automated Glycohemoglobin Analyzer HLC-723G8?

Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is manufactured by Tosoh Bioscience, Inc..

What is the FDA product code for Tosoh Automated Glycohemoglobin Analyzer HLC-723G8?

The FDA product code for Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is PDJ.

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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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