EUROIMMUN Anti-BP230-CF ELISA (IgG)
K-Number: K193115 · 2020-09-17
ApplicantEuroimmun Us, Inc.
Decision Date2020-09-17
Product CodeOEG
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
EUROIMMUN Anti-BP230-CF ELISA (IgG) is a medical device manufactured by Euroimmun Us, Inc.. It received FDA 510(k) clearance on 2020-09-17 under approval number K193115. The device is classified under product code OEG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EUROIMMUN Anti-BP230-CF ELISA (IgG)?
EUROIMMUN Anti-BP230-CF ELISA (IgG) is a medical device that received FDA 510(k) clearance on 2020-09-17. It is manufactured by Euroimmun Us, Inc.. The 510(k) number is K193115.
When was EUROIMMUN Anti-BP230-CF ELISA (IgG) approved by the FDA?
EUROIMMUN Anti-BP230-CF ELISA (IgG) received FDA 510(k) clearance on 2020-09-17, under approval number K193115.
What company makes EUROIMMUN Anti-BP230-CF ELISA (IgG)?
EUROIMMUN Anti-BP230-CF ELISA (IgG) is manufactured by Euroimmun Us, Inc..
What is the FDA product code for EUROIMMUN Anti-BP230-CF ELISA (IgG)?
The FDA product code for EUROIMMUN Anti-BP230-CF ELISA (IgG) is OEG.
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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.