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FDA 510(k)

QScout Lab; QScout RLD

K-Number: K230878 · 2023-11-14

ApplicantAd Astra Diagnostics, Inc.
Decision Date2023-11-14
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QScout Lab; QScout RLD is a medical device manufactured by Ad Astra Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-11-14 under approval number K230878. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QScout Lab; QScout RLD?

QScout Lab; QScout RLD is a medical device that received FDA 510(k) clearance on 2023-11-14. It is manufactured by Ad Astra Diagnostics, Inc.. The 510(k) number is K230878.

When was QScout Lab; QScout RLD approved by the FDA?

QScout Lab; QScout RLD received FDA 510(k) clearance on 2023-11-14, under approval number K230878.

What company makes QScout Lab; QScout RLD?

QScout Lab; QScout RLD is manufactured by Ad Astra Diagnostics, Inc..

What is the FDA product code for QScout Lab; QScout RLD?

The FDA product code for QScout Lab; QScout RLD is GKZ.

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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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