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FDA 510(k)

IS-RUBELLA IGG TEST SYSTEM

K-Number: K981729 · 1999-01-28

ApplicantDiamedix Corp.
Decision Date1999-01-28
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IS-RUBELLA IGG TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 1999-01-28 under 510(k) number K981729. 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 IS-RUBELLA IGG TEST SYSTEM?

IS-RUBELLA IGG TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-01-28. The listed applicant is Diamedix Corp.. The 510(k) number is K981729.

When did IS-RUBELLA IGG TEST SYSTEM receive FDA 510(k) clearance?

IS-RUBELLA IGG TEST SYSTEM received FDA 510(k) clearance on 1999-01-28, under 510(k) number K981729.

Who is the listed applicant for IS-RUBELLA IGG TEST SYSTEM?

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

What is the FDA product code for IS-RUBELLA IGG TEST SYSTEM?

The FDA product code for IS-RUBELLA IGG TEST SYSTEM is LFX.

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Other records listing Diamedix Corp. 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.

K093101MAGO 4SK021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

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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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