Alinity i Toxo IgM
K-Number: K233932 · 2024-08-30
ApplicantAbbott Laboratories
Decision Date2024-08-30
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Alinity i Toxo IgM is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2024-08-30 under approval number K233932. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Alinity i Toxo IgM?
Alinity i Toxo IgM is a medical device that received FDA 510(k) clearance on 2024-08-30. It is manufactured by Abbott Laboratories. The 510(k) number is K233932.
When was Alinity i Toxo IgM approved by the FDA?
Alinity i Toxo IgM received FDA 510(k) clearance on 2024-08-30, under approval number K233932.
What company makes Alinity i Toxo IgM?
Alinity i Toxo IgM is manufactured by Abbott Laboratories.
What is the FDA product code for Alinity i Toxo IgM?
The FDA product code for Alinity i Toxo IgM is LGD.
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Related Devices (Code: LGD)
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.