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FDA 510(k)

IMX TOXO IGG

K-Number: K951636 · 1995-08-01

ApplicantAbbott Laboratories
Decision Date1995-08-01
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMX 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 1995-08-01 under 510(k) number K951636. 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 IMX TOXO IGG?

IMX TOXO IGG is a medical device that received FDA 510(k) clearance on 1995-08-01. The listed applicant is Abbott Laboratories. The 510(k) number is K951636.

When did IMX TOXO IGG receive FDA 510(k) clearance?

IMX TOXO IGG received FDA 510(k) clearance on 1995-08-01, under 510(k) number K951636.

Who is the listed applicant for IMX 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 IMX TOXO IGG?

The FDA product code for IMX TOXO IGG is LGD.

Other records listing Abbott Laboratories 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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