EliA RNA Pol III
K-Number: K202541 · 2021-09-13
ApplicantPhadia AB
Decision Date2021-09-13
Product CodeNYO
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EliA RNA Pol III is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2021-09-13 under approval number K202541. The device is classified under product code NYO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EliA RNA Pol III?
EliA RNA Pol III is a medical device that received FDA 510(k) clearance on 2021-09-13. It is manufactured by Phadia AB. The 510(k) number is K202541.
When was EliA RNA Pol III approved by the FDA?
EliA RNA Pol III received FDA 510(k) clearance on 2021-09-13, under approval number K202541.
What company makes EliA RNA Pol III?
EliA RNA Pol III is manufactured by Phadia AB.
What is the FDA product code for EliA RNA Pol III?
The FDA product code for EliA RNA Pol III is NYO.
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
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K151029Phadia Prime
K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
K183007EliA SmDP Immunoassay
Related Devices (Code: NYO)
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.