EliA SmDP-S— 510(k) K202067

Substantially Equivalent

Phadia AB

FDA 510(k) clearance K202067 for EliA SmDP-S, Substantially Equivalent on 2021-07-14. Applicant: Phadia AB. Device class: 2.

Clearance details

Applicant
Phadia AB
Product code
Code LKP
Device class
Class 2
Regulation
21 CFR 866.5100
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Uppsala, SE
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Data sourced from openFDA. This site is unofficial and independent of the FDA.