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510(k) K053012

FIDIS VASCULITIS, MODEL MX007 by Biomedical Diagnostics (Bmd) SA — Product Code MOB

K053012 is an FDA 510(k) premarket notification submitted by Biomedical Diagnostics (Bmd) SA for the device "FIDIS VASCULITIS, MODEL MX007". The FDA issued a decision of Substantially Equivalent on March 2, 2006. The device falls under product code MOB (Test System, Antineutrophil Cytoplasmic Antibodies (Anca)), a Class II device regulated under 21 CFR 866.5660. Biomedical Diagnostics (Bmd) SA has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2006
Date Received
October 26, 2005
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 Biomedical Diagnostics (Bmd) SA

  • K102607 — FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS (December 3, 2010)
  • K100917 — FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM (November 3, 2010)
  • K070458 — MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 (December 21, 2007)
  • K071210 — MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006 (December 19, 2007)
  • K061794 — FIDIS TM THYRO, MODEL MX002 (November 21, 2006)
  • K060380 — FIDIS DSDNA (May 2, 2006)
  • K053383 — FIDIS CELIAC (March 29, 2006)
  • K053653 — FIDIS CONNECTIVE 10, MODEL MX006 (March 13, 2006)
  • K050286 — FIDIS CONNECTIVE 8 (October 3, 2005)

Other clearances for product code MOB

  • 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)
  • K092599 — IMMULISA MPO ANTIBODY ELISA (October 7, 2010)

FDA data resources