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510(k) K041040

VARELISA MPO ANCA, MODEL 17648/17696 by Sweden Diagnostics (Germany) GmbH — Product Code MOB

K041040 is an FDA 510(k) premarket notification submitted by Sweden Diagnostics (Germany) GmbH for the device "VARELISA MPO ANCA, MODEL 17648/17696". The FDA issued a decision of Substantially Equivalent on June 16, 2004. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Sweden Diagnostics (Germany) GmbH has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2004
Date Received
April 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
Device Class
Class II
Regulation Number
866.5660
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)
  • K041354 — VARELISA GLIADIN IGA ANTIBODIES MODEL #19848/19896 (July 16, 2004)

Other clearances for product code MOB

  • K261466 — Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBM (August 21, 2026)
  • K243776 — Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplas (May 7, 2025)
  • K172582 — EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte (May 24, 2018)
  • K172461 — AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (March 23, 2018)
  • K173792 — EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay (March 13, 2018)
  • K161258 — NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (February 3, 2017)
  • K140225 — ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GB (October 27, 2014)
  • K112545 — QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM (July 31, 2012)
  • K100917 — FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (November 3, 2010)
  • K092601 — IMMULISA ANCA SCREEN ELISA (October 7, 2010)

FDA data resources