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510(k) K123713

IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA by Immco Diagnostics, Inc. — Product Code MVM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2013
Date Received
December 4, 2012
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

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  • K113020 — IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) (October 25, 2012)
  • K113143 — IMMULISA SCI-70 ANTIBODY ELISA (December 2, 2011)

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  • K102490 — IGX PLEX CELIAC QUALITATIVE ASSAY (June 2, 2011)
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  • K102964 — EU-TTG IGA AND EU-TTG IGG (March 7, 2011)
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