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510(k) K041174

CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 by Sweden Diagnostics (Germany) GmbH — Product Code MVM

K041174 is an FDA 510(k) premarket notification submitted by Sweden Diagnostics (Germany) GmbH for the device "CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196". The FDA issued a decision of Substantially Equivalent on July 19, 2004. The device falls under product code MVM (Autoantibodies, Endomysial(Tissue Transglutaminase)), a Class II device regulated under 21 CFR 866.5660. Sweden Diagnostics (Germany) GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2004
Date Received
May 5, 2004
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 Sweden Diagnostics (Germany) GmbH

  • K050967 — VARELISA RECOMBI CTD SCREEN, MODEL 13096 (June 28, 2005)
  • K050625 — VARELISA RECOMBI ANA PROFILE, MODEL 18496 (April 26, 2005)
  • K042629 — VARELISA SM ANTIBODIES, MODEL 18296 (December 8, 2004)
  • K041173 — CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 (August 2, 2004)
  • K041357 — VARELISA GLIADIN IGG ANTIBODIES (August 2, 2004)
  • K041354 — VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 (July 16, 2004)
  • K041040 — VARELISA MPO ANCA, MODEL 17648/17696 (June 16, 2004)

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