Alinity i Rubella IgG
K-Number: K243168 · 2025-06-20
ApplicantAbbott Laboratories
Decision Date2025-06-20
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Alinity i Rubella IgG is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2025-06-20 under approval number K243168. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alinity i Rubella IgG?
Alinity i Rubella IgG is a medical device that received FDA 510(k) clearance on 2025-06-20. It is manufactured by Abbott Laboratories. The 510(k) number is K243168.
When was Alinity i Rubella IgG approved by the FDA?
Alinity i Rubella IgG received FDA 510(k) clearance on 2025-06-20, under approval number K243168.
What company makes Alinity i Rubella IgG?
Alinity i Rubella IgG is manufactured by Abbott Laboratories.
What is the FDA product code for Alinity i Rubella IgG?
The FDA product code for Alinity i Rubella IgG is LFX.
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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.