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510(k) K041354

VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 by Sweden Diagnostics (Germany) GmbH — Product Code MST

K041354 is an FDA 510(k) premarket notification submitted by Sweden Diagnostics (Germany) GmbH for the device "VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896". The FDA issued a decision of Substantially Equivalent on July 16, 2004. The device falls under product code MST (Antibodies, Gliadin), a Class II device regulated under 21 CFR 866.5750. Sweden Diagnostics (Germany) GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2004
Date Received
May 20, 2004
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

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)
  • K041174 — CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196 (July 19, 2004)
  • K041040 — VARELISA MPO ANCA, MODEL 17648/17696 (June 16, 2004)

Other clearances for product code MST

  • K163177 — ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Anti (July 28, 2017)
  • K132082 — AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK (December 5, 2013)
  • K113377 — GLIADIN IGA AND GLIADIN LGA (December 14, 2012)
  • 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)

FDA data resources