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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 the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2019-11-29 under 510(k) 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. The listed applicant is Phadia AB. The 510(k) number is K190710.

When did EliA SymphonyS Immunoassay receive FDA 510(k) clearance?

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

Who is the listed applicant for EliA SymphonyS Immunoassay?

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

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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