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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K242095.

When did Access Toxo IgM II receive FDA 510(k) clearance?

Access Toxo IgM II received FDA 510(k) clearance on 2024-10-11, under 510(k) number K242095.

Who is the listed applicant for Access Toxo IgM II?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Access Toxo IgM II?

The FDA product code for Access Toxo IgM II is LGD.

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LGD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242022Access Toxo IgGBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche Diagnostics

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.

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