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FDA 510(k)

MAGO 4S

K-Number: K093101 · 2011-01-21

ApplicantDiamedix Corp.
Decision Date2011-01-21
Product CodeLFX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MAGO 4S is the device name listed in this FDA 510(k) record. The listed applicant is Diamedix Corp.. It received FDA 510(k) clearance on 2011-01-21 under 510(k) number K093101. 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 MAGO 4S?

MAGO 4S is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Diamedix Corp.. The 510(k) number is K093101.

When did MAGO 4S receive FDA 510(k) clearance?

MAGO 4S received FDA 510(k) clearance on 2011-01-21, under 510(k) number K093101.

Who is the listed applicant for MAGO 4S?

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 MAGO 4S?

The FDA product code for MAGO 4S is LFX.

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.

K021394DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEMK013956DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREENK013628DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEMK012449DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEMK012450DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEMK012795DIAMEDIX IS-ANTI-GLIADIN IGG 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.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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