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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2018-11-27 under 510(k) 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. The listed applicant is Phadia AB. The 510(k) number is K182353.

When did EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay receive FDA 510(k) clearance?

EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay received FDA 510(k) clearance on 2018-11-27, under 510(k) number K182353.

Who is the listed applicant for EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 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 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.

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