Home / 510(k) Clearances / K143736

510(k) K143736

ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA by Immco Diagnostics, Inc. — Product Code DHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2015
Date Received
December 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Rheumatoid Factor
Device Class
Class II
Regulation Number
866.5775
Review Panel
IM
Submission Type

Other clearances by Immco Diagnostics, Inc.

  • K172745 — ImmuGlo HEp-2 Elite IFA (June 5, 2018)
  • K172078 — ImmuLisa Enhanced RNA POL III Antibody ELISA (March 30, 2018)
  • K163133 — ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Anti (August 8, 2017)
  • K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Anti (July 28, 2017)
  • K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody (June 19, 2017)
  • K151559 — ImmuLisa Enhanced Centromere Antibody ELISA (March 11, 2016)
  • K142781 — ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody (March 31, 2015)
  • K123713 — IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA (October 25, 2013)
  • K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) (October 25, 2012)
  • K113143 — IMMULISA SCI-70 ANTIBODY ELISA (December 2, 2011)

Other clearances for product code DHR

  • K192727 — K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (May 20, 2020)
  • K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (April 17, 2019)
  • K182747 — EliA RF IgM Immunoassay (December 18, 2018)
  • K162263 — Optilite Rheumatoid Factor Kit (May 3, 2017)
  • K160070 — Rheumatoid Factor (RF) Kit for use on SPAPLUS (December 7, 2016)
  • K102673 — RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM (September 30, 2011)
  • K100499 — ORGENTEC RHEUMATOID FACTOR EIA (October 27, 2010)
  • K083080 — IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM (October 29, 2009)
  • K071247 — N LATEX RF KIT (August 8, 2007)
  • K060201 — OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028 (June 6, 2006)