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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 the device name listed in this FDA 510(k) record. The listed applicant is Tosoh Bioscience, Inc.. It received FDA 510(k) clearance on 2021-08-05 under 510(k) 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. The listed applicant is Tosoh Bioscience, Inc.. The 510(k) number is K200904.

When did Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 receive FDA 510(k) clearance?

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

Who is the listed applicant for Tosoh Automated Glycohemoglobin Analyzer HLC-723G8?

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-723G8?

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

K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01K211199ST AIA-PACK BNP AssayPMA P910065Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancerK160113ST AIA-PACK hsE2 Calibrator Set

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.

K252749Medconn 8K Glycated Hemoglobin Test SystemShanghai Medconn Medical Technology Co., Ltd.K250073Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01Tosoh Bioscience, Inc.K242911Medconn Glycated Hemoglobin Test systemShanghai Medconn Medical Technology Co., Ltd.K220999Hipro Glycosylated Hemoglobin (HbA1c) Test SystemShijiazhuang Hipro Biotechnology Co., Ltd.K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.K193053Tina-quant Hemoglobin A1cDx Gen.3Roche Diagnostics Operations (Rdo)

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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