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510(k) K032850

IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGG) by Immco Diagnostics, Inc. — Product Code NBT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2004
Date Received
September 12, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Device Class
Class II
Regulation Number
866.5785
Review Panel
IM
Submission Type

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  • 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 NBT

  • K071711 — ASCA-CHEK (November 7, 2007)
  • K051927 — TECHLAB ASCA-CHEK (April 6, 2006)
  • K051492 — AESKULISA ASCA A (November 14, 2005)
  • K042579 — BINDAZYME HUMAN ASCA IGG AND IGA EIA DIAGNOSTIC TEST KIT (July 28, 2005)
  • K032860 — IMMULISA ANTI-SACCHAROMYCES CEREVISIAE ANTIBODY (ASCA) (IGA) (March 18, 2004)
  • K000733 — QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA (May 21, 2001)
  • DEN000007 — QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA (August 16, 2000)