EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay
K-Number: K182353 · 2018-11-27
ApplicantPhadia AB
Decision Date2018-11-27
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2018-11-27 under approval number K182353. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay?
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay is a medical device that received FDA 510(k) clearance on 2018-11-27. It is manufactured by Phadia AB. The 510(k) number is K182353.
When was EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay approved by the FDA?
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay received FDA 510(k) clearance on 2018-11-27, under approval number K182353.
What company makes EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay?
EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay is manufactured by Phadia AB.
What is the FDA product code for EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay?
The FDA product code for EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay is LJM.
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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.