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FDA 510(k)

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay

K-Number: K173792 · 2018-03-13

ApplicantPhadia AB
Decision Date2018-03-13
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM 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 2018-03-13 under 510(k) number K173792. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay?

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay is a medical device that received FDA 510(k) clearance on 2018-03-13. The listed applicant is Phadia AB. The 510(k) number is K173792.

When did EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay receive FDA 510(k) clearance?

EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay received FDA 510(k) clearance on 2018-03-13, under 510(k) number K173792.

Who is the listed applicant for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM 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 PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay?

The FDA product code for EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay is MOB.

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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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