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FDA 510(k)

EliA SymphonyS Immunoassay

K-Number: K190710 · 2019-11-29

ApplicantPhadia AB
Decision Date2019-11-29
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EliA SymphonyS Immunoassay is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2019-11-29 under approval number K190710. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EliA SymphonyS Immunoassay?

EliA SymphonyS Immunoassay is a medical device that received FDA 510(k) clearance on 2019-11-29. It is manufactured by Phadia AB. The 510(k) number is K190710.

When was EliA SymphonyS Immunoassay approved by the FDA?

EliA SymphonyS Immunoassay received FDA 510(k) clearance on 2019-11-29, under approval number K190710.

What company makes EliA SymphonyS Immunoassay?

EliA SymphonyS Immunoassay is manufactured by Phadia AB.

What is the FDA product code for EliA SymphonyS Immunoassay?

The FDA product code for EliA SymphonyS Immunoassay is LLL.

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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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