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FDA 510(k)

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay

K-Number: K181871 · 2019-03-01

ApplicantPhadia AB
Decision Date2019-03-01
Product CodeMVM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2019-03-01 under approval number K181871. The device is classified under product code MVM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay?

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by Phadia AB. The 510(k) number is K181871.

When was EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay approved by the FDA?

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay received FDA 510(k) clearance on 2019-03-01, under approval number K181871.

What company makes EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay?

EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay is manufactured by Phadia AB.

What is the FDA product code for EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay?

The FDA product code for EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay is MVM.

Other Devices by Phadia AB

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Related Devices (Code: MVM)

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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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