Home / 510(k) Clearances / K062708

510(k) K062708

QUANTA LITE CELIAC DGP SCREEN by Inova Diagnostics, Inc. — Product Code MST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2006
Date Received
September 11, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibodies, Gliadin
Device Class
Class II
Regulation Number
866.5750
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 MST

  • K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Anti (July 28, 2017)
  • K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (December 5, 2013)
  • K113377 — GLIADIN IGA AND GLIADIN LGA (December 14, 2012)
  • K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QU (September 20, 2012)
  • K111414 — QUANTA FLASH (TM) DGP SCREEN (October 20, 2011)
  • K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5 (August 13, 2010)
  • K091522 — IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA (February 4, 2010)
  • K083053 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) (August 7, 2009)
  • K083052 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) (July 28, 2009)
  • K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (M (October 15, 2008)