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FDA 510(k)

Alinity h-series System

K-Number: K220031 · 2023-08-04

ApplicantAbbott Laboratories
Decision Date2023-08-04
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Alinity h-series System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K220031. 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 Alinity h-series System?

Alinity h-series System is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Abbott Laboratories. The 510(k) number is K220031.

When did Alinity h-series System receive FDA 510(k) clearance?

Alinity h-series System received FDA 510(k) clearance on 2023-08-04, under 510(k) number K220031.

Who is the listed applicant for Alinity h-series System?

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 Alinity h-series System?

The FDA product code for Alinity h-series System is GKZ.

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Related Devices (Code: GKZ)

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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