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FDA 510(k)

URight Hemoglobin A1c system, FORA A1c System

K-Number: K142664 · 2016-01-29

ApplicantTaidoc Technology Corporation
Decision Date2016-01-29
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

URight Hemoglobin A1c system, FORA A1c System is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2016-01-29 under 510(k) number K142664. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URight Hemoglobin A1c system, FORA A1c System?

URight Hemoglobin A1c system, FORA A1c System is a medical device that received FDA 510(k) clearance on 2016-01-29. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K142664.

When did URight Hemoglobin A1c system, FORA A1c System receive FDA 510(k) clearance?

URight Hemoglobin A1c system, FORA A1c System received FDA 510(k) clearance on 2016-01-29, under 510(k) number K142664.

Who is the listed applicant for URight Hemoglobin A1c system, FORA A1c System?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for URight Hemoglobin A1c system, FORA A1c System?

The FDA product code for URight Hemoglobin A1c system, FORA A1c System is LCP.

Other records listing Taidoc Technology Corporation as applicant

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Related Devices (Code: LCP)

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.

K221326Nova Allegro HbA1c Assay, Nova Allegro AnalyzerNova Biomedical CorporationK231465Q-Pad Test SystemQurasenseK214117Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 AnalyzerAbbott Diagnostics Technologies ASK192987Aina HbA1c Monitoring System 2Jana Care, Inc.K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitIxensor Co, Ltd.K183230OneDraw A1C Test SystemDrawbridge Health, 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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