Access Toxo IgM II
K-Number: K242095 · 2024-10-11
ApplicantBeckman Coulter, Inc.
Decision Date2024-10-11
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Access Toxo IgM II is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-10-11 under approval number K242095. 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 IgM II?
Access Toxo IgM II is a medical device that received FDA 510(k) clearance on 2024-10-11. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K242095.
When was Access Toxo IgM II approved by the FDA?
Access Toxo IgM II received FDA 510(k) clearance on 2024-10-11, under approval number K242095.
What company makes Access Toxo IgM II?
Access Toxo IgM II is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access Toxo IgM II?
The FDA product code for Access Toxo IgM II 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.