Alinity h-series System
K-Number: K243283 · 2025-02-20
ApplicantAbbott Laboratories
Decision Date2025-02-20
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 2025-02-20 under approval number K243283. 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 2025-02-20. It is manufactured by Abbott Laboratories. The 510(k) number is K243283.
When was Alinity h-series System approved by the FDA?
Alinity h-series System received FDA 510(k) clearance on 2025-02-20, under approval number K243283.
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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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.