EliA M2 Immunoassay
K-Number: K181556 · 2018-07-13
ApplicantPhadia AB
Decision Date2018-07-13
Product CodeDBM
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EliA M2 Immunoassay is a medical device manufactured by Phadia AB. It received FDA 510(k) clearance on 2018-07-13 under approval number K181556. The device is classified under product code DBM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EliA M2 Immunoassay?
EliA M2 Immunoassay is a medical device that received FDA 510(k) clearance on 2018-07-13. It is manufactured by Phadia AB. The 510(k) number is K181556.
When was EliA M2 Immunoassay approved by the FDA?
EliA M2 Immunoassay received FDA 510(k) clearance on 2018-07-13, under approval number K181556.
What company makes EliA M2 Immunoassay?
EliA M2 Immunoassay is manufactured by Phadia AB.
What is the FDA product code for EliA M2 Immunoassay?
The FDA product code for EliA M2 Immunoassay is DBM.
Other Devices by Phadia AB
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Related Devices (Code: DBM)
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.