EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG)— 510(k) K083053

Name: FDA 510(k) clearance K083053
Creator: U.S. Food and Drug Administration
Published: 2009-08-07

Substantially Equivalent

Euroimmun Us, Inc.

FDA 510(k) clearance K083053 for EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG), Substantially Equivalent on 2009-08-07. Applicant: Euroimmun Us, Inc.. Device class: 2.

Clearance details

Applicant: Euroimmun Us, Inc.
Product code: Code MST
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 2008-10-14
Decision date: 2009-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morristown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MST

view all

K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA2017-07-28
K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK2013-12-05
K113377 — GLIADIN IGA AND GLIADIN LGA2012-12-14
K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS2012-09-20
K111414 — QUANTA FLASH (TM) DGP SCREEN2011-10-20

More clearances from Euroimmun Us, Inc.

view all

K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG)2020-09-17
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

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