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FDA 510(k)

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS

K-Number: K052499 · 2006-02-08

ApplicantDiasorin S.P.A
Decision Date2006-02-08
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin S.P.A. It received FDA 510(k) clearance on 2006-02-08 under 510(k) number K052499. 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 DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS?

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS is a medical device that received FDA 510(k) clearance on 2006-02-08. The listed applicant is Diasorin S.P.A. The 510(k) number is K052499.

When did DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS receive FDA 510(k) clearance?

DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS received FDA 510(k) clearance on 2006-02-08, under 510(k) number K052499.

Who is the listed applicant for DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS?

The FDA 510(k) record lists Diasorin S.P.A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS?

The FDA product code for DIASORIN LIAISON TOXO IGG AND LIAISON TOXO IGM ASSAYS is LGD.

Related Clinical Trials

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Other records listing Diasorin S.P.A 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.

K040290DIASORIN LIAISON CMV IGM/IGG

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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