Home / 510(k) Clearances / K092736

510(k) K092736

EUROIMMUN ANTI-M2-3E ELISA (IGG) by Euroimmun Us, Inc. — Product Code DBM

K092736 is an FDA 510(k) premarket notification submitted by Euroimmun Us, Inc. for the device "EUROIMMUN ANTI-M2-3E ELISA (IGG)". The FDA issued a decision of Substantially Equivalent on September 2, 2010. The device falls under product code DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5090. Euroimmun Us, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2010
Date Received
September 4, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5090
Review Panel
IM
Submission Type

Other clearances by Euroimmun Us, Inc.

  • 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 DBM

  • K181556 — EliA M2 Immunoassay (July 13, 2018)
  • K163525 — QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT (September 5, 2017)
  • K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Anti (August 8, 2017)
  • K141375 — ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250 (February 13, 2015)
  • K052262 — QUANTA LITE M2 EP (MIT3) ELISA (October 27, 2005)
  • K031308 — RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760 (September 26, 2003)
  • K030238 — BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT (March 24, 2003)
  • K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT (September 17, 1998)
  • K971909 — VIRGO AMA ELISA KIT (June 20, 1997)
  • K962452 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA (November 25, 1996)

FDA data resources