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FDA 510(k)

Tina-quant Hemoglobin A1cDx Gen.3

K-Number: K193053 · 2020-03-26

ApplicantRoche Diagnostics Operations (Rdo)
Decision Date2020-03-26
Product CodePDJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Tina-quant Hemoglobin A1cDx Gen.3 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations (Rdo). It received FDA 510(k) clearance on 2020-03-26 under 510(k) number K193053. 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 Tina-quant Hemoglobin A1cDx Gen.3?

Tina-quant Hemoglobin A1cDx Gen.3 is a medical device that received FDA 510(k) clearance on 2020-03-26. The listed applicant is Roche Diagnostics Operations (Rdo). The 510(k) number is K193053.

When did Tina-quant Hemoglobin A1cDx Gen.3 receive FDA 510(k) clearance?

Tina-quant Hemoglobin A1cDx Gen.3 received FDA 510(k) clearance on 2020-03-26, under 510(k) number K193053.

Who is the listed applicant for Tina-quant Hemoglobin A1cDx Gen.3?

The FDA 510(k) record lists Roche Diagnostics Operations (Rdo) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tina-quant Hemoglobin A1cDx Gen.3?

The FDA product code for Tina-quant Hemoglobin A1cDx Gen.3 is PDJ.

Other records listing Roche Diagnostics Operations (Rdo) 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.

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.K200904Tosoh Automated Glycohemoglobin Analyzer HLC-723G8Tosoh Bioscience, Inc.K200256ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) AssaySiemens Healthcare Diagnostics, Inc.

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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