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FDA 510(k)

Abbott Architect Free T4

K-Number: K173122 · 2017-10-27

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

Device Summary

Abbott Architect Free T4 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2017-10-27 under 510(k) 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. The listed applicant is Abbott Laboratories. The 510(k) number is K173122.

When did Abbott Architect Free T4 receive FDA 510(k) clearance?

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

Who is the listed applicant for Abbott Architect Free T4?

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

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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Related Devices (Code: CEC)

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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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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