EliA SmDP Immunoassay
K-Number: K183007 · 2018-12-24
ApplicantPhadia AB
Decision Date2018-12-24
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EliA SmDP Immunoassay is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2018-12-24 under approval number K183007. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EliA SmDP Immunoassay?
EliA SmDP Immunoassay is a medical device that received FDA 510(k) clearance on 2018-12-24. It is manufactured by Phadia AB. The 510(k) number is K183007.
When was EliA SmDP Immunoassay approved by the FDA?
EliA SmDP Immunoassay received FDA 510(k) clearance on 2018-12-24, under approval number K183007.
What company makes EliA SmDP Immunoassay?
EliA SmDP Immunoassay is manufactured by Phadia AB.
What is the FDA product code for EliA SmDP Immunoassay?
The FDA product code for EliA SmDP Immunoassay is LKP.
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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.