FDA 510(k)

Quo-Test A1c System

K-Number: K180509 · 2019-02-16

Decision Date2019-02-16

Product CodeLCP

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

Quo-Test A1c System is a medical device manufactured by Ekf-Diagnostic GmbH. It received FDA 510(k) clearance on 2019-02-16 under approval 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. It is manufactured by Ekf-Diagnostic GmbH. The 510(k) number is K180509.

When was Quo-Test A1c System approved by the FDA?

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

What company makes Quo-Test A1c System?

Quo-Test A1c System is manufactured by Ekf-Diagnostic GmbH.

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

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

Other Devices by Ekf-Diagnostic GmbH

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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.