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510(k) K010625

EUROSPITAL EU-TTG IGA UMANA by Scimedx Corp. — Product Code MVM

K010625 is an FDA 510(k) premarket notification submitted by Scimedx Corp. for the device "EUROSPITAL EU-TTG IGA UMANA". The FDA issued a decision of Substantially Equivalent on April 24, 2001. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Scimedx Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2001
Date Received
March 2, 2001
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 Scimedx Corp.

  • K011348 — PHASE II GBM IGG ANTIBODY EIA TEST (June 25, 2001)
  • K011082 — TPO IGG ANTIBODY EIA TEST (June 6, 2001)
  • K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA (March 16, 2001)
  • K010289 — SCIMEDX PHASE II MPO IGG ANTIBODY EIA (March 7, 2001)
  • K002169 — GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002189 — GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002107 — IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CO (August 4, 2000)
  • K994379 — EU-TTG IGA ELISA (February 18, 2000)
  • K970198 — IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES (February 20, 1997)
  • K962360 — IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES (September 30, 1996)

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)

FDA data resources