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510(k) K954105

EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES by Scimedx Corp. — Product Code MOB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1996
Date Received
August 31, 1995
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 Scimedx Corp.

  • K011348 — PHASE II GBM IGG ANTIBODY EIA TEST (June 25, 2001)
  • K011082 — TPO IGG ANTIBODY EIA TEST (June 6, 2001)
  • K010625 — EUROSPITAL EU-TTG IGA UMANA (April 24, 2001)
  • K010287 — SCIMEDX PHASE II PR3 IGG ANTIBODY EIA (March 16, 2001)
  • K010289 — SCIMEDX PHASE II MPO IGG ANTIBODY EIA (March 7, 2001)
  • K002189 — GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002169 — GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM (October 19, 2000)
  • K002107 — IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CO (August 4, 2000)
  • K994379 — EU-TTG IGA ELISA (February 18, 2000)
  • K970198 — IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES (February 20, 1997)

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