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FDA 510(k)

LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM

K-Number: K122397 · 2012-09-06

ApplicantDiaSorin, Inc.
Decision Date2012-09-06
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2012-09-06 under 510(k) number K122397. The device is classified under product code LFX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM?

LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM is a medical device that received FDA 510(k) clearance on 2012-09-06. The listed applicant is DiaSorin, Inc.. The 510(k) number is K122397.

When did LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM receive FDA 510(k) clearance?

LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM received FDA 510(k) clearance on 2012-09-06, under 510(k) number K122397.

Who is the listed applicant for LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM?

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

What is the FDA product code for LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM?

The FDA product code for LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM is LFX.

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Related Devices (Code: LFX)

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.

K250588Access Rubella IgGBeckman Coulter, Inc.K243168Alinity i Rubella IgGAbbott LaboratoriesK093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche DiagnosticsK080766VIDAS RUB IGGbioMerieux, 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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