EliA RF IgM Immunoassay
K-Number: K182747 · 2018-12-18
ApplicantPhadia AB
Decision Date2018-12-18
Product CodeDHR
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EliA RF IgM Immunoassay is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2018-12-18 under approval number K182747. The device is classified under product code DHR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EliA RF IgM Immunoassay?
EliA RF IgM Immunoassay is a medical device that received FDA 510(k) clearance on 2018-12-18. It is manufactured by Phadia AB. The 510(k) number is K182747.
When was EliA RF IgM Immunoassay approved by the FDA?
EliA RF IgM Immunoassay received FDA 510(k) clearance on 2018-12-18, under approval number K182747.
What company makes EliA RF IgM Immunoassay?
EliA RF IgM Immunoassay is manufactured by Phadia AB.
What is the FDA product code for EliA RF IgM Immunoassay?
The FDA product code for EliA RF IgM Immunoassay is DHR.
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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.