FDA 510(k)

EliA SmDP-S

K-Number: K202067 · 2021-07-14

Decision Date2021-07-14

Product CodeLKP

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

EliA SmDP-S is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K202067. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EliA SmDP-S?

EliA SmDP-S is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Phadia AB. The 510(k) number is K202067.

When did EliA SmDP-S receive FDA 510(k) clearance?

EliA SmDP-S received FDA 510(k) clearance on 2021-07-14, under 510(k) number K202067.

Who is the listed applicant for EliA SmDP-S?

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 SmDP-S?

The FDA product code for EliA SmDP-S is LKP.

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 Screen K212181ImmunoCAP 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 seed K210902EliA Ro52, EliA Ro60 K202541EliA RNA Pol III K202540EliA Rib-P K200279ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine

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Related Devices (Code: LKP)

K183007EliA SmDP ImmunoassayPhadia AB

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.