EliA Ro52, EliA Ro60
K-Number: K210902 · 2022-07-27
ApplicantPhadia AB
Decision Date2022-07-27
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EliA Ro52, EliA Ro60 is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2022-07-27 under approval number K210902. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EliA Ro52, EliA Ro60?
EliA Ro52, EliA Ro60 is a medical device that received FDA 510(k) clearance on 2022-07-27. It is manufactured by Phadia AB. The 510(k) number is K210902.
When was EliA Ro52, EliA Ro60 approved by the FDA?
EliA Ro52, EliA Ro60 received FDA 510(k) clearance on 2022-07-27, under approval number K210902.
What company makes EliA Ro52, EliA Ro60?
EliA Ro52, EliA Ro60 is manufactured by Phadia AB.
What is the FDA product code for EliA Ro52, EliA Ro60?
The FDA product code for EliA Ro52, EliA Ro60 is LKJ.
Other Devices by Phadia AB
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K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
K151029Phadia Prime
K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
K183007EliA SmDP Immunoassay
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.