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510(k) K051458

WIESLAB CAP PR-3 ANCA by Eurodiagnostica — Product Code MOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2005
Date Received
June 2, 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 Eurodiagnostica

  • K052133 — IMMUNOSCAN RA ANTI-CCP TEST SYSTEM (December 12, 2005)
  • K051455 — WIESLAB CAP MPO-ANCA (November 23, 2005)

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  • 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)
  • K092600 — IMMULISA PR3 ANTIBODY ELISA (October 7, 2010)
  • K092601 — IMMULISA ANCA SCREEN ELISA (October 7, 2010)