Access Toxo IgG
K-Number: K242022 · 2025-03-28
ApplicantBeckman Coulter, Inc.
Decision Date2025-03-28
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Access Toxo IgG is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-03-28 under approval number K242022. 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 Access Toxo IgG?
Access Toxo IgG is a medical device that received FDA 510(k) clearance on 2025-03-28. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K242022.
When was Access Toxo IgG approved by the FDA?
Access Toxo IgG received FDA 510(k) clearance on 2025-03-28, under approval number K242022.
What company makes Access Toxo IgG?
Access Toxo IgG is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access Toxo IgG?
The FDA product code for Access Toxo IgG 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.