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510(k) K112545

QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM by Inova Diagnostics, Inc. — Product Code MOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2012
Date Received
September 1, 2011
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

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