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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2022-05-19 under 510(k) 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. The listed applicant is Abbott Laboratories. The 510(k) number is K210596.

When did ARCHITECT Toxo IgG receive FDA 510(k) clearance?

ARCHITECT Toxo IgG received FDA 510(k) clearance on 2022-05-19, under 510(k) number K210596.

Who is the listed applicant for ARCHITECT Toxo IgG?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT Toxo IgG?

The FDA product code for ARCHITECT Toxo IgG is LGD.

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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 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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