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FDA 510(k)

Abbott Architect Free T4

K-Number: K173122 · 2017-10-27

Decision Date2017-10-27
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Abbott Architect Free T4 is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2017-10-27 under approval number K173122. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Abbott Architect Free T4?

Abbott Architect Free T4 is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Abbott Laboratories. The 510(k) number is K173122.

When was Abbott Architect Free T4 approved by the FDA?

Abbott Architect Free T4 received FDA 510(k) clearance on 2017-10-27, under approval number K173122.

What company makes Abbott Architect Free T4?

Abbott Architect Free T4 is manufactured by Abbott Laboratories.

What is the FDA product code for Abbott Architect Free T4?

The FDA product code for Abbott Architect Free T4 is CEC.

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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.