EUROIMMUN Anti-BP230-CF ELISA (IgG)— 510(k) K193115

Name: FDA 510(k) clearance K193115
Creator: U.S. Food and Drug Administration
Published: 2020-09-17

Substantially Equivalent

Euroimmun Us, Inc.

FDA 510(k) clearance K193115 for EUROIMMUN Anti-BP230-CF ELISA (IgG), Substantially Equivalent on 2020-09-17. Applicant: Euroimmun Us, Inc.. Device class: 2.

Clearance details

Applicant: Euroimmun Us, Inc.
Product code: Code OEG
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2019-11-12
Decision date: 2020-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OEG

view all

K083615 — EUROIMMUN ANTI BP 180-4X ELISA (IGG)2009-03-16
K071961 — MESACUP MODELS BP180 AND BP230 ELISA KITS2008-08-25

More clearances from Euroimmun Us, Inc.

view all

K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)2019-02-28
K172582 — EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern2018-05-24
K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern2018-04-20
K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern2018-04-20
K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)2017-12-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.