ARCHITECT Toxo IgG
K-Number: K210596 · 2022-05-19
ApplicantAbbott Laboratories
Decision Date2022-05-19
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
ARCHITECT Toxo IgG is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2022-05-19 under approval number K210596. 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 ARCHITECT Toxo IgG?
ARCHITECT Toxo IgG is a medical device that received FDA 510(k) clearance on 2022-05-19. It is manufactured by Abbott Laboratories. The 510(k) number is K210596.
When was ARCHITECT Toxo IgG approved by the FDA?
ARCHITECT Toxo IgG received FDA 510(k) clearance on 2022-05-19, under approval number K210596.
What company makes ARCHITECT Toxo IgG?
ARCHITECT Toxo IgG is manufactured by Abbott Laboratories.
What is the FDA product code for ARCHITECT Toxo IgG?
The FDA product code for ARCHITECT Toxo IgG is LGD.
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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.