EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay
K-Number: K181329 · 2018-06-25
ApplicantPhadia AB
Decision Date2018-06-25
Product CodeMSV
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2018-06-25 under approval number K181329. The device is classified under product code MSV. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is a medical device that received FDA 510(k) clearance on 2018-06-25. It is manufactured by Phadia AB. The 510(k) number is K181329.
When was EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay approved by the FDA?
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay received FDA 510(k) clearance on 2018-06-25, under approval number K181329.
What company makes EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?
EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is manufactured by Phadia AB.
What is the FDA product code for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay?
The FDA product code for EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay is MSV.
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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.