Home / 510(k) Clearances / K131791

510(k) K131791

IFA 40: HEP-20-10 by Euroimmun US — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2014
Date Received
June 18, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Euroimmun US

  • K193115 — EUROIMMUN Anti-BP230-CF ELISA (IgG) (September 17, 2020)
  • K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transg (February 28, 2019)
  • K172582 — EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte (May 24, 2018)
  • K172244 — EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern (April 20, 2018)
  • K172252 — EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern (April 20, 2018)
  • K172722 — Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) (December 10, 2017)
  • K161513 — Anti-Borrelia burgdorferi US Westernblot (IgG) (August 25, 2016)
  • K153308 — EUROIMMUN Anti-West Nile Virus ELISA (IgM) (August 12, 2016)
  • K153303 — EUROIMMUN Anti-West Nile Virus ELISA (IgG) (August 10, 2016)
  • K142038 — EUROIMMUN LYME ELISA(IgG/IgM) (May 4, 2015)

Other clearances for product code DHN

  • K201956 — Zeus IFA ANA HEp-2 Test System, Zeus dIFine (April 29, 2022)
  • K172745 — ImmuGlo HEp-2 Elite IFA (June 5, 2018)
  • K153117 — AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM (July 28, 2016)
  • K160265 — Image Navigator by Immuno Concepts (June 17, 2016)
  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)
  • K150155 — NOVA Lite DAPI ANA Kit (April 8, 2015)
  • K120889 — AESKUSLIDES ANA HEP-2 (October 15, 2012)
  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)
  • K024220 — LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 (January 17, 2003)