EUROIMMUN Anti-West Nile Virus ELISA (IgM)
K-Number: K153308 · 2016-08-12
ApplicantEuroimmun Us, Inc.
Decision Date2016-08-12
Product CodeNOP
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
EUROIMMUN Anti-West Nile Virus ELISA (IgM) is a medical device manufactured by Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2016-08-12 under approval number K153308. The device is classified under product code NOP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EUROIMMUN Anti-West Nile Virus ELISA (IgM)?
EUROIMMUN Anti-West Nile Virus ELISA (IgM) is a medical device that received FDA 510(k) clearance on 2016-08-12. It is manufactured by Euroimmun Us, Inc.. The 510(k) number is K153308.
When was EUROIMMUN Anti-West Nile Virus ELISA (IgM) approved by the FDA?
EUROIMMUN Anti-West Nile Virus ELISA (IgM) received FDA 510(k) clearance on 2016-08-12, under approval number K153308.
What company makes EUROIMMUN Anti-West Nile Virus ELISA (IgM)?
EUROIMMUN Anti-West Nile Virus ELISA (IgM) is manufactured by Euroimmun Us, Inc..
What is the FDA product code for EUROIMMUN Anti-West Nile Virus ELISA (IgM)?
The FDA product code for EUROIMMUN Anti-West Nile Virus ELISA (IgM) is NOP.
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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.