Home / 510(k) Clearances / K113143

510(k) K113143

IMMULISA SCI-70 ANTIBODY ELISA by Immco Diagnostics, Inc. — Product Code LLL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2011
Date Received
October 25, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Extractable Antinuclear Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
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)
  • K143736 — ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA (September 23, 2015)
  • 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)

Other clearances for product code LLL

  • K250666 — Alegria Flash CTD Screen (October 22, 2025)
  • K250408 — Alegria Flash ENA Screen (September 19, 2025)
  • K213403 — Aptiva CTD Essential Reagent (September 29, 2023)
  • K190710 — EliA SymphonyS Immunoassay (November 29, 2019)
  • K180975 — QUANTA Flash HMGCR Reagents (June 25, 2018)
  • K152635 — QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Contro (June 1, 2016)
  • K151429 — QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrol (February 12, 2016)
  • K142781 — ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody (March 31, 2015)
  • K141328 — QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS (February 12, 2015)
  • K141210 — QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS (January 29, 2015)