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FDA 510(k)

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl

K-Number: K162678 · 2017-06-23

ApplicantRoche Diagnostics
Decision Date2017-06-23
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K162678. 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 Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Roche Diagnostics. The 510(k) number is K162678.

When did Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl receive FDA 510(k) clearance?

Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl received FDA 510(k) clearance on 2017-06-23, under 510(k) number K162678.

Who is the listed applicant for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?

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

What is the FDA product code for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl?

The FDA product code for Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl is LGD.

Other records listing Roche Diagnostics as applicant

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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 Laboratories

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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