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510(k) K071692

THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS by Theratest Laboratories, Inc. — Product Code MVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2007
Date Received
June 20, 2007
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 Theratest Laboratories, Inc.

  • K090753 — THERATEST EL-ANTI-CCP/2 (March 5, 2010)
  • K090760 — THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-12 (September 3, 2009)
  • K061376 — EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3 (July 20, 2006)
  • K060176 — EL-ACL SCREEN; EL-ACL IGM, IGG, IGA (February 7, 2006)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K040291 — EL-ANA PROFILES: ANTI-CHROMATIN (March 11, 2004)
  • K024151 — EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P (February 6, 2003)
  • K024031 — THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE (February 6, 2003)
  • K002559 — EL-ANA PROFILES-2K1 (September 12, 2000)
  • K982150 — EL-ANA PROFILES: EL-ENA/4 (August 13, 1998)

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  • 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)