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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2021-09-13 under 510(k) 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. The listed applicant is Phadia AB. The 510(k) number is K202541.

When did EliA RNA Pol III receive FDA 510(k) clearance?

EliA RNA Pol III received FDA 510(k) clearance on 2021-09-13, under 510(k) number K202541.

Who is the listed applicant for EliA RNA Pol III?

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 RNA Pol III?

The FDA product code for EliA RNA Pol III is NYO.

Other records listing Phadia AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253367EliA CTD 13 ScreenK212181ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seedK210902EliA Ro52, EliA Ro60K202540EliA Rib-PK202067EliA SmDP-SK200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

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Related Devices (Code: NYO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172078ImmuLisa Enhanced RNA POL III Antibody ELISAImmco Diagnostics, Inc.

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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