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510(k) K042644

AESKULISA TTG A AND AESKULISA TTG G by Aesku, Inc. — Product Code MVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2005
Date Received
September 27, 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 Aesku, Inc.

  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)
  • K051492 — AESKULISA ASCA A (November 14, 2005)
  • K040953 — AESKULISA ANA HEP-2 (June 23, 2004)
  • K040463 — AESKULISA CARDIOLIPIN AGM (May 12, 2004)
  • K032469 — AESKULISA ANA 8PRO (December 16, 2003)

Other clearances for product code MVM

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  • 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)