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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 a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2023-08-04 under approval 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. It is manufactured by Abbott Laboratories. The 510(k) number is K220031.

When was Alinity h-series System approved by the FDA?

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

What company makes Alinity h-series System?

Alinity h-series System is manufactured by Abbott Laboratories.

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 PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

Other Devices by Abbott Laboratories

K153375ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls K153730ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control K173122Abbott Architect Free T4 K170320Alinity c ICT Sample Diluent K170317Alinity i Total ß-hCG Reagent Kit, Alinity i System K170316ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM

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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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