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510(k) K113377

GLIADIN IGA AND GLIADIN LGA by Grifols USA, LLC — Product Code MST

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2012
Date Received
November 16, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antibodies, Gliadin
Device Class
Class II
Regulation Number
866.5750
Review Panel
IM
Submission Type

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Other clearances for product code MST

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  • K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (December 5, 2013)
  • K113863 — QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QU (September 20, 2012)
  • K111414 — QUANTA FLASH (TM) DGP SCREEN (October 20, 2011)
  • K093459 — ELIA GLIADIN DP IGA IMMUNOASSAY AND ELIA GLIADIN DP IGG IMMUNOASSAY, MODELS 14-5 (August 13, 2010)
  • K091522 — IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA (February 4, 2010)
  • K083053 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGG) (August 7, 2009)
  • K083052 — EUROIMMUN ANTI-GLIADIN (GAF-3X) ELISA (IGA) (July 28, 2009)
  • K081674 — BINDAZYME HUMAN ANTI-GLIADIN (MGP), IGG EIA KIT; BINDAZYME HUMAN ANTI-GLIADIN (M (October 15, 2008)
  • K063775 — ELIA GLIADIN IGA, IGG AND CELIAC CONTROL (March 14, 2007)