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510(k) K994379

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2000
Date Received
December 27, 1999
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)
  • K010625 — EUROSPITAL EU-TTG IGA UMANA (April 24, 2001)
  • K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA (March 16, 2001)
  • K010289 — SCIMEDX PHASE II MPO IGG ANTIBODY EIA (March 7, 2001)
  • K002189 — GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002169 — GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002107 — IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CO (August 4, 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)

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  • K140691 — IG_PLEX CELIAC DGP PANEL (November 6, 2014)
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  • K102490 — IGX PLEX CELIAC QUALITATIVE ASSAY (June 2, 2011)
  • K101644 — QUANTA FLASH H-TTG IGG (March 23, 2011)
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