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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 the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) 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. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K250073.

When did Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 receive FDA 510(k) clearance?

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

Who is the listed applicant for Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01?

The FDA 510(k) record lists Tosoh Bioscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Tosoh Bioscience, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: PDJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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