FDA 510(k)

EliA SmDP Immunoassay

K-Number: K183007 · 2018-12-24

Decision Date2018-12-24

Product CodeLKP

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

EliA SmDP Immunoassay is the device name listed in this FDA 510(k) record. The listed applicant is Phadia AB. It received FDA 510(k) clearance on 2018-12-24 under 510(k) number K183007. 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 Immunoassay?

EliA SmDP Immunoassay is a medical device that received FDA 510(k) clearance on 2018-12-24. The listed applicant is Phadia AB. The 510(k) number is K183007.

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

EliA SmDP Immunoassay received FDA 510(k) clearance on 2018-12-24, under 510(k) number K183007.

Who is the listed applicant for EliA SmDP Immunoassay?

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 Immunoassay?

The FDA product code for EliA SmDP Immunoassay 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 K202067EliA SmDP-S

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Related Devices (Code: LKP)

K202067EliA SmDP-SPhadia 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.