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FDA 510(k)

Quo-Test A1c System

K-Number: K180509 · 2019-02-16

ApplicantEkf-Diagnostic GmbH
Decision Date2019-02-16
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Quo-Test A1c System is the device name listed in this FDA 510(k) record. The listed applicant is Ekf-Diagnostic GmbH. It received FDA 510(k) clearance on 2019-02-16 under 510(k) number K180509. 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 Quo-Test A1c System?

Quo-Test A1c System is a medical device that received FDA 510(k) clearance on 2019-02-16. The listed applicant is Ekf-Diagnostic GmbH. The 510(k) number is K180509.

When did Quo-Test A1c System receive FDA 510(k) clearance?

Quo-Test A1c System received FDA 510(k) clearance on 2019-02-16, under 510(k) number K180509.

Who is the listed applicant for Quo-Test A1c System?

The FDA 510(k) record lists Ekf-Diagnostic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quo-Test A1c System?

The FDA product code for Quo-Test A1c System is LCP.

Other records listing Ekf-Diagnostic GmbH 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: 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

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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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