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FDA 510(k)

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01

K-Number: K250073 · 2025-10-03

ApplicantTosoh Bioscience, Inc.
Decision Date2025-10-03
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is a medical device manufactured by Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2025-10-03 under approval number K250073. 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-723GR01?

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by Tosoh Bioscience, Inc.. The 510(k) number is K250073.

When was Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 approved by the FDA?

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 received FDA 510(k) clearance on 2025-10-03, under approval number K250073.

What company makes Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01?

Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 is manufactured by Tosoh Bioscience, Inc..

What is the FDA product code for Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01?

The FDA product code for Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 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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