EliA SmDP-S
K-Number: K202067 · 2021-07-14
ApplicantPhadia AB
Decision Date2021-07-14
Product CodeLKP
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EliA SmDP-S is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2021-07-14 under approval 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. It is manufactured by Phadia AB. The 510(k) number is K202067.
When was EliA SmDP-S approved by the FDA?
EliA SmDP-S received FDA 510(k) clearance on 2021-07-14, under approval number K202067.
What company makes EliA SmDP-S?
EliA SmDP-S is manufactured by Phadia AB.
What is the FDA product code for EliA SmDP-S?
The FDA product code for EliA SmDP-S is LKP.
Other Devices by Phadia AB
K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
K150597ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite
K151029Phadia Prime
K163370ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE
K183007EliA SmDP Immunoassay
Related Devices (Code: LKP)
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.