Home / 510(k) Clearances / K072632

510(k) K072632

QUANTA PLEX CELIAC IGG PROFILE by Inova Diagnostics, Inc. — Product Code MVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2008
Date Received
September 18, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autoantibodies, Endomysial(Tissue Transglutaminase)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

Other clearances by Inova Diagnostics, Inc.

  • K243979 — Aptiva APS IgA Reagent (February 6, 2026)
  • K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (December 17, 2024)
  • K213403 — Aptiva CTD Essential Reagent (September 29, 2023)
  • K200230 — Aptiva Celiac Disease IgG Reagent (August 26, 2021)
  • K193604 — Aptiva Celiac Disease IgA Reagent (June 16, 2021)
  • K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit (December 11, 2020)
  • K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (April 17, 2019)
  • K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device (October 16, 2018)
  • K180975 — QUANTA Flash HMGCR Reagents (June 25, 2018)
  • K170993 — QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANT (December 22, 2017)

Other clearances for product code MVM

  • K200230 — Aptiva Celiac Disease IgG Reagent (August 26, 2021)
  • K193604 — Aptiva Celiac Disease IgA Reagent (June 16, 2021)
  • K181871 — EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG (March 1, 2019)
  • K183313 — EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transg (February 28, 2019)
  • K140691 — IG_PLEX CELIAC DGP PANEL (November 6, 2014)
  • K123713 — IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA (October 25, 2013)
  • K130053 — BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200 CE (September 19, 2013)
  • K102490 — IGX PLEX CELIAC QUALITATIVE ASSAY (June 2, 2011)
  • K101644 — QUANTA FLASH H-TTG IGG (March 23, 2011)
  • K102964 — EU-TTG IGA AND EU-TTG IGG (March 7, 2011)