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 a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2018-03-13 under approval 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. It is manufactured by Phadia AB. The 510(k) number is K173792.
When was EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay approved by the FDA?
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay received FDA 510(k) clearance on 2018-03-13, under approval number K173792.
What company makes EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay?
EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay is manufactured by Phadia AB.
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.