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FDA 510(k)

ELECSYS RUBELLA IGG IMMUNOASSAY

K-Number: K072617 · 2008-12-05

ApplicantRoche Diagnostics Corp.
Decision Date2008-12-05
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ELECSYS RUBELLA IGG IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2008-12-05 under 510(k) number K072617. 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 ELECSYS RUBELLA IGG IMMUNOASSAY?

ELECSYS RUBELLA IGG IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2008-12-05. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K072617.

When did ELECSYS RUBELLA IGG IMMUNOASSAY receive FDA 510(k) clearance?

ELECSYS RUBELLA IGG IMMUNOASSAY received FDA 510(k) clearance on 2008-12-05, under 510(k) number K072617.

Who is the listed applicant for ELECSYS RUBELLA IGG IMMUNOASSAY?

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

What is the FDA product code for ELECSYS RUBELLA IGG IMMUNOASSAY?

The FDA product code for ELECSYS RUBELLA IGG IMMUNOASSAY is LFX.

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Other records listing Roche Diagnostics Corp. as applicant

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K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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 LaboratoriesK122397LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGMDiaSorin, Inc.K093101MAGO 4SDiamedix Corp.K092587BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEMBio-Rad LaboratoriesK092322ELECSYS RUBELLA IGM IMMUNOASSAYRoche 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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