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FDA 510(k)

ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY

K-Number: K032162 · 2003-08-08

ApplicantBeckman Coulter, Inc.
Decision Date2003-08-08
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY 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 2003-08-08 under 510(k) number K032162. 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 IMMUNOASSAY SYSTEM TOXO IGG ASSAY?

ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K032162.

When did ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY receive FDA 510(k) clearance?

ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY received FDA 510(k) clearance on 2003-08-08, under 510(k) number K032162.

Who is the listed applicant for ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY?

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 IMMUNOASSAY SYSTEM TOXO IGG ASSAY?

The FDA product code for ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY is LGD.

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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.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, Inc.

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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